Capital Reporting Company Homeopathic Product Regulation 04-20-2015

Homeopathic Product Regulation:

Evaluating the Food And Drug Administration's

Regulatory Framework After a Quarter-Century

Part 15 Public Hearing

Day 1

Monday, April 20, 2015

9:00 a.m.

FDA White Oak Campus

10903 New Hampshire Avenue

Bldg 31, Room 1503(A)

Silver Spring, Maryland 20993

Reported by: Michael Farkas Capital Reporting Company

2 1 A P P E A R A N C E S

2 JANET WOODCOCK

3 JOHN WHYTE

4 EDWARD P. KRENZELOK

5 ADRIANE FUGH-BERMAN

6 MICHAEL DEDORA

7 WAYNE B. JONAS

8 LISA AMERINE

9 AMY ROTHENBERG

10 BRUCE H. SHELTON

11 JEANNINE RITCHOT

12 MELANIE GRIMES

13 MARCEL FRAIX

14 M'LOU ARNETT

15 ALISON TEITELBAUM

16 JANINE JAGGER

17 MARK LAND

18 MARK PHILLIPS

19 ERIC FOXMAN

20 BARBARA A. KOCHANOWSKI

21 PEGGY O'MARA

22 LUANA COLLOCA

3 1 APPEARANCES CONTINUED:

2 ALYSSE WOSTREL 3 NANCY PEPLINSKY 4 TANYA KELL 5 ANTHONY VOZZOLO 6

4 1 C O N T E N T S

2 SPEAKER: PAGE NUMBER:

3 John Whyte, Moderator 6

4 Janet Woodcock, Director, CDER, FDA 6

5 Edward Krenzelok, Rocky Mountain Poison and Drug Center 17 6 Adriane Fugh-Berman, 7 Georgetown University Medical Center 35

8 Michael DeDora, Center for Inquiry 50

9 Wayne B. Jonas, Samueli Institute 62

10 Lisa Amerine, Homeopathic Academy of Naturopathic Physicians 87 11 Dr. Bruce H. Shelton, Arizona Homeopathic 12 and Integrative Medical Association 131

13 Jeannine Ritchot, Health Canada 153

14 Melanie Grimes 173

15 Dr. Marcel Fraix, Western University of Health Sciences 179 16 M'Lou Arnett, Matrixx Initiatives, Inc. 191 17 Alison Teitelbaum, 18 Natural Center for Homeopathy 203

19 Janine Jagger, Familial Mediterranean Fever Found. 210 20 Dr. Mark Land, Mark Phillips, Eric Foxman 218 21 American Assoc. of Homeopathic Pharmacists

22 Barbara A. Kochanowski, Consumer Healthcare Products Assoc. 248

5 1 Peggy O'Mara 259 2 Luana Colloca, Univ. of Maryland, Baltimore 269 3 Alyssa Wostrel, 4 Integrative Health Policy Consortium 287

5 Nancy Peplinsky, Holistic Moms Network 301

6 Tanya Kell, North American Society of Homeopaths 311 7

6 1 P R O C E E D I N G S

2 DR. WHYTE: Well, good morning,

3 everyone. I'm Dr. John Whyte. I'm the Director of

4 Professional Affairs and Stakeholder Engagement

5 Group here at the Food and Drug Administration at

6 the Center for Drugs Evaluation and Research, and

7 I'll be serving as the moderator for today's

8 hearing.

9 We're on a strict timeline today so I

10 want to go ahead and get started, and I'm

11 delighted to present to you Dr. Janet Woodcock,

12 who is the Director of the Center for Drugs

13 Evaluation and Research.

14 DR. WOODCOCK: Thanks very much, John.

15 Good morning, everyone. Thank you very much for

16 coming to this. I'd like to welcome you to this

17 two day hearing on FDA's regulation on drug

18 products labeled as homeopathic.

19 We recognize that this topic is of great

20 importance and of interest to industry and other

21 stakeholders based on the number of presenters

22 scheduled to speak here today and tomorrow.

7 1 I want to thank you for all your

2 interest in this topic and thank the people in the

3 webcast, and hope that they are able to access

4 this event.

5 By providing specific feedback to our

6 questions and our preliminary concepts, through

7 your oral testimony and written comments to FDA's

8 dockets, you will help us develop the appropriate

9 path forward.

10 The Federal Food, Drug, and Cosmetic

11 Act, and I'll refer to it as the ACT, recognizes

12 articles listed in the Homeopathic Pharmacopoeia

13 of the United States as drugs. FDA has clear

14 regulatory authority over drug products labeled as

15 homeopathic, just as it does with all products

16 that meet the definition of "drug" in the ACT.

17 And I know there's been a great deal of confusion

18 about this, but yes, FDA has authority over drugs

19 that are labeled as homeopathic.

20 However, under FDA's current enforcement

21 policies that were issued in something we call a

22 Compliance Policy Guide, in 1988 drug products

8 1 labeled as homeopathic are marketed without pre-

2 market approval, provided those products are

3 marketed in accordance with certain conditions,

4 including ones related to labeling and

5 manufacturing.

6 So, it isn't that homeopathic drugs are

7 not regulated by the FDA, they are regulated as

8 drugs, it's simply they have a different structure

9 right now under this compliance policy guide

10 that's been in effect for a long time as far as

11 how they are regulated.

12 Today, prescription and non prescription

13 drugs labeled as homeopathic are a multi-billion

14 dollar industry in the United States.

15 A majority of drug products that are

16 labeled as homeopathic are marketed and sold

17 direct consumer through magazines, the internet,

18 and in both the big box retail establishments and

19 traditional pharmacy retail outlets.

20 Prescription drug products labeled

21 homeopathic also exist and are available through

22 both online pharmacies and through practitioners

9 1 licensed to dispense prescription drug products.

2 So there are several outlets -- great over-the-

3 counter use, direct to consumer, and also

4 prescription use.

5 Typically drug products are brought to

6 the market through the new drug approval process,

7 or via an over-the-counter monograph, and these

8 are two regulatory structures that FDA has in

9 place to allow new drugs or traditional drugs to

10 be marketed.

11 In contrast, both prescription and non

12 prescription drug products that are labeled as

13 homeopathic are manufactured and distributed

14 without FDA approval, and without being subject to

15 any FDA monograph under the Agency's enforcement

16 policies that were set forth, as I mentioned, in

17 this compliance policy guide. So, that is the

18 regulatory -- currently regulatory regime for

19 these homeopathic products.

20 The public hearing, we hope, will allow

21 FDA to obtain information about such products in

22 an effort to better promote and protect the public

10 1 health, which is what we do, which is our mission.

2 And we want to make sure that patients have the

3 necessary information to make informed choices

4 about products labeled as homeopathic, as well as,

5 of course, make sure that all those products are

6 appropriately safe for people to use.

7 FDA is seeking input on several

8 questions regarding products labeled as

9 homeopathic, that include various topic areas;

10 consumer and healthcare provider attitudes,

11 potential data sources that could be used to

12 assess the risks and benefits of the products, our

13 enforcement policies, and the evaluation processes

14 for over-the-counter products, and labeling.

15 These are just a few of the many items

16 that we hope to gain a great deal of information

17 and insight on over the next two days of this

18 meeting.

19 So, in closing, homeopathic products are

20 of interest and are used by many Americans. They

21 are available both by prescription and greatly

22 through over-the-counter sources. FDA has clear

11 1 regulatory authority over these products, however,

2 under our Compliance Policy Guide, we basically

3 are mainly looking at instances where there's

4 reports of harm, or other reports, when we

5 regulate these products, and they're not subject

6 to the kind of premarket review or monograph that

7 all the other traditional drug products are

8 required to comply with.

9 So, we seek information. It's time for

10 an update. It's time to look at how we're

11 regulating this class of products, and we really

12 look forward to your input, and thank you very

13 much for being here. Thanks.

14 DR. WHYTE: Well, thank you, Dr.

15 Woodcock. So, as Dr. Woodcock said, this is being

16 webcast, so I thought I would give you the web

17 address if you want to take out any pen and paper.

18 It's www.collaboration.fda.gov/hprapril2015.

19 Again. www.collaboration.fda.gov/hprapril2015.

20 All right. Just a few housekeeping

21 rules before we get started because we're all

22 excited to have this discussion. I know a lot of

12 1 you have travelled to come here and we have, as

2 you can see, a packed room.

3 This meeting will be held in accordance

4 with Part 15, and that's a special type of

5 hearing, part of the 21CFR, Part 15. I want to

6 remind you that the hearing is informal and the

7 rules of evidence do not apply.

8 I ask that no participant interrupt the

9 presentation of any other participant, only the

10 presiding officer and panel members may question

11 any person during or at the conclusion of each

12 presentation. This really is a listening session

13 on behalf of the Food and Drug Administration.

14 So, I'm going to call you up to the

15 podium by name when it's your turn and I'll ask

16 you to introduce yourself. I ask that you state

17 your name and organization for the record.

18 In anticipation of the hearing

19 presentation moving ahead on schedule, I really

20 encourage you to arrive early, so if any

21 colleagues or friends are coming, I do ask that

22 you have them come a couple of hours early because

13 1 things can move quickly. If you're not present

2 when you're called upon, you actually may forfeit

3 your time. Those are the general rules of the

4 hearing.

5 If you have any financial interest

6 relevant to the meetings, such as a financial

7 relationship with any company or group that may

8 be affected by the topic of this meeting, the FDA

9 encourages you to state that interest when you

10 begin your presentation. If you don't have any

11 such interest, you may wish to state that for the

12 record as well.

13 And I must add, if you prefer not to

14 disclose your financial interest, you can still

15 give your presentation.

16 I do want to remind you that

17 presentations will be strictly limited to the time

18 allocated in the agenda, and hopefully all of you

19 have a copy of the agenda. There's a timer right

20 up here that you'll be able to see when you

21 present. It will turn yellow when there's 30

22 seconds remaining for each presentation.

14 1 So, again, when it flashes yellow,

2 that's 30 seconds, and this will be your warning

3 to conclude your talk.

4 The light will turn red when your time

5 is up, and I'm told that the microphone will cease

6 to work. So hopefully we won't have to resort to

7 that and we can all be gentile and conclude our

8 time when the red light comes up. I don't want to

9 have to be a traffic cop.

10 And following each presentation, there

11 will be a period of five minutes, which will also

12 be strictly enforced, where the panel members

13 actually can ask any follow-up questions, or I may

14 have an opportunity to ask you to clarify

15 anything.

16 I do want to add, after the meeting,

17 because people always ask about -- you know, "I

18 didn't get a chance to talk at the meeting," or "I

19 wanted to make these other comments," if you do

20 have additional information, or you know other

21 folks that want to present information to the FDA,

22 you can still submit electronic comments regarding

15 1 the public hearing to regulations.gov, and any

2 written comments to the Division of Dockets

3 Management, and I don't know if we'll have a slide

4 where we can put that, but I'll give it to you

5 just in case. It's 5630 Fishers Lane, Room 1061,

6 in Rockville, Maryland.

7 You can annotate and organize your

8 comments to identify specific questions on the

9 topic to which they refer, but I do want to

10 caution you that they must be received by June

11 22nd, 2015.

12 So, again, there is opportunity to make

13 any additional comments or opposing questions, and

14 you have until June 22nd, 2015.

15 One other housekeeping note, we will

16 have a break this morning prior to lunch, and

17 during that time I encourage you -- there is a

18 kiosk where you can preorder your lunch, so you

19 might want to do that because you will not be able

20 to enter other aspects of the building, such as

21 the FDA's cafeteria. So if you want to order

22 lunch, there will be a kiosk where you can

16 1 preorder.

2 With that, I'll turn to the panel who

3 will have an opportunity to introduce themselves.

4 DR. BENT: Hello. Good morning. My

5 name is Dr. Kate Bent. I'm the Assistant

6 Commissioner for Compliance Policy in the Office

7 of Regulatory Affairs.

8 DR. IZEM: Good morning. I'm Dr. Rima

9 Izem. I'm a Team Leader in the Office of

10 Biostatistics.

11 MS. LIPPMANN: Good morning. My name is

12 Elaine Lippmann. I'm Regulatory Counsel in the

13 Office of Regulatory Policy.

14 DR. LOSTRITTO: Good morning. I'm Rick

15 Lostritto. I'm a Division Director in the Office

16 of Policy for Product Quality. I'm also the

17 acting Associate Director for Science in that

18 office.

19 MS. MICHELE: Good morning. I'm Teresa

20 Michele. I'm the Division Director of Non-

21 Prescription Drug Products in the Office of New

22 Drugs.

17 1 DR. NELSON: I'm Dr. Robert Nelson. I'm

2 Deputy Director of the Office of Pediatric

3 Therapeutics in the Office of the Commissioner.

4 MR. PACE: Hi. I'm Brad Pace. I'm

5 Regulatory Counsel in the Office of Compliance in

6 the Center for Drugs.

7 MR. WU: Good morning. My name is

8 Charles Wu. I'm part of the review team of the

9 Office of Pharmaceutical Quality.

10 DR. WHYTE: I'll also introduce our

11 timekeepers for the day. I should caution, this

12 isn't their day job, so please indulge us. Dave

13 Boggs and Imo Zadezensky. So they will help us

14 also with any issues that you may be experiencing.

15 It does look very high tech when you get

16 up here, in front of you, but just use this little

17 gadget to advance your slides forward if you're

18 using any slides.

19 And with that, we'll go ahead and get

20 started. Our first speaker is Edward Krenzelok

21 from the Rocky Mountain Poison and Drug Center.

22 MR. KRENZELOK: Good morning. Thank

18 1 you, Dr. Whyte, Dr. Woodcock, members of the

2 panel, members of the audience. It's certainly a

3 pleasure to be here. Here we are.

4 So, I'm Edward Krenzelok. I am a

5 consulting Clinical Toxicologist with the Rocky

6 Mountain Poison Center in Denver. I'm a former

7 Director of the Pittsburgh Poison Center, for

8 about 30 years, and I also hold the position and

9 title of Professor Emeritus (ph) at the University

10 of Pittsburgh School of Pharmacy.

11 This study, the data, that I'm going to

12 discuss this morning was funded by a grant to the

13 Rocky Mountain Poison Center by the Consumer

14 Healthcare Products Association, and I'm -- my

15 time is being compensated by the Rocky Mountain

16 Poison Center.

17 And I would like you just to pay

18 attention -- this is a very long disclaimer from

19 the AAPCC -- but as we get down here to the end,

20 "exposures do not necessarily represent poisoning

21 or overdose," and I think that's the key part of

22 this that I'd like you to remember during my

19 1 presentation, if you would, please.

2 So, I don't know if you know a lot about

3 America's poison center system, but there are 55

4 Poison Centers in the U.S. They all belong to

5 the American Association of Poison Control

6 Centers. They are all connected via a universal

7 800 number, so if you have a poisoning, an

8 exposure, and adverse reaction, something of that

9 nature, call 1- 800-222-1222. It will route you

10 to the nearest poison center in any of the 50

11 states or any of the U.S. Territories.

12 These services are available every day

13 of the year, 24 hours a day, so it's a wonderful

14 emergency service.

15 Every case that comes in, every

16 exposure, every inquiry, is documented

17 electronically on a medical record. Those data

18 are then auto uploaded automatically to the

19 National Poison Data System at the AAPCC, so it's

20 a real time database of all exposures that are

21 reported.

22 Every year the AAPCC publishes its data

20 1 and you can data and you can see a citation right

2 here, and at the conclusion of my slides are eight

3 references for the eight years of data that I'm

4 going to discuss. And so it discusses both

5 pharmaceutical and non pharmaceutical product

6 exposures.

7 Now, remember, every exposure is not a

8 poisoning. Every exposure is not associated with

9 an adverse event, and the data that I'm going to

10 be addressing today are from the eight year period

11 of 2006 to 2013, and they are single product

12 exposures.

13 So, these aren't multi-pharmaceutical

14 exposures where multiple substances have been

15 ingested. It's single product exposures, and we

16 gleaned all of the data, not from a special data

17 run, but from these publications that you have

18 full access to. If you go to AAPCC.org, all of

19 these data are available for you immediately.

20 I'd like to walk you through, just very

21 briefly, what a call might be coming in to a

22 poison center, and the intake methods.

21 1 So, the call comes in to the poison

2 center. It's received by a specialist in poison

3 information who is a Pharmacist or a Nurse,

4 generally. They will then determine if this is an

5 intentional exposure, an unintentional exposure,

6 an adverse reaction, or some other reason for

7 people to call.

8 They'll ultimately issue some

9 recommendations and they'll do follow-up if at all

10 possible, and then report it all to the National

11 Poison Data System. So, again, that forms the

12 basis for the data that I will be discussion this

13 morning.

14 Now, as you can see, there were

15 19,037,967 exposures of all sorts, pharmaceutical

16 and non-pharmaceutical, reported over those eight

17 years to American Poison Centers.

18 If we follow down, we can see that there

19 were just over 12 million single product

20 exposures, and that's, again, what I'm focusing

21 on. Eight million of those were pharmaceuticals,

22 and then as we get down to homeopathic agents,

22 1 which is the focus of my presentation, it's 80,456

2 exposures, so, that forms the basis for all the

3 data that I will be presenting to you. And,

4 again, just to reemphasize, these are single

5 product exposures.

6 This breaks down for you on an annual

7 basis as well how many exposures there are and

8 gives you a perspective. So basically, the

9 homeopathic exposures account for about one

10 percent of all exposures reported to American

11 poison centers as they relate to pharmaceutical

12 agents, single exposure, pharmaceutical agents.

13 And I also will be, then, discussing the

14 age of the victims -- of the people that had the

15 exposures -- basically why they were exposed,

16 their outcome, and then ultimately their

17 disposition as well -- were they hospitalized or

18 not -- in my brief presentation.

19 So, let's take a look at this first

20 data, and I'll be comparing those to all

21 pharmaceutical data so you have a perspective on

22 homeopathic products versus all pharmaceuticals.

23 1 So, you can see that the vast majority

2 of the exposures as reported to American poison

3 centers involve children less than six years of

4 age. Very clearly -- you know, 92% -- and that's

5 quite different from what it is when we look at

6 all pharmaceutical products in general, whereas

7 all pharmaceutical account for just over half of

8 the exposures reported to poison centers.

9 And then you can see the disparity in

10 the age groups, in six to 19, and greater than 20

11 being adults, and these are the way the data are

12 broken down again in the annual reports. So,

13 there are more definitive data, but those data

14 have to be requested specifically from the AAPCC.

15 So, this gives you a perspective on age, so it is

16 a pediatric issue more than anything else.

17 And then as we look at the reason for

18 exposure -- remember I talked about unintentional,

19 intentional, adverse reactions, and so on --

20 unintentional, think of as accidental exposure.

21 It may be a child getting into a container, or

22 sampling some tablets that were left on a table,

24 1 or whatever the exposure may be. Or someone

2 accidentally -- an adult picking up someone else's

3 medication. So those are the accidental or

4 unintentional exposures.

5 And you can see that intentional

6 exposures, which can be suicide, substance abuse,

7 and so on, are extremely low with this particular

8 group.

9 Now, when we compare that to all

10 pharmaceuticals, you can see, again, there's a

11 significant disparity, and the intentional

12 exposures are very significantly different

13 compared to the homeopathic agents, again,

14 probably because they have no abuse potential.

15 And we see a lot of these exposures as

16 being substance abuse -- and then you also will

17 look over here and see that there were some

18 adverse reactions and about twice as many adverse

19 reactions involving regular pharmaceutical

20 exposure as compared to the homeopathic agents.

21 And then, as we look outcome, which is

22 very important, let's look first at the affect.

25 1 There is no affect. That basically means it's

2 pretty obvious -- no affect -- the child, the

3 adult, whoever was exposed suffered absolutely no

4 adverse event. And there were -- about 10% of

5 those exposures ended up having some type of a

6 minor event.

7 So, you can see that over 98% of the

8 exposures to the homeopathic agents resulted in

9 either no affect or only a minor affect.

10 Note also that there are a couple of

11 deaths reported. Unfortunately I can't provide

12 you with any information because I'm only

13 providing you with information that was published

14 information, and these data regarding the

15 specifics on these fatalities are sort of buried

16 in the AAPC database and have to be extracted

17 separately.

18 Comparing those to all pharmaceuticals,

19 again, you can see significant differences as in

20 each other slide that I've presented. A lot more

21 minor affects, a lot more moderate affects, major

22 affects -- and there's about a six times

26 1 difference in fatality rates between and among all

2 pharmaceuticals versus the homeopathic agents.

3 And then finally, what happens? Where

4 are these people treated? What's their ultimate

5 disposition?

6 So, approximately 5.8% of all of the

7 homeopathic exposure patients end up in an

8 emergency department or seeking some type of

9 healthcare outside of just a call to the Poison

10 Center, versus about five times the number with

11 all pharmaceuticals.

12 And I must tell you that this isn't

13 necessarily because a poison center recommended

14 they go to an emergency department, this could be

15 people going to an emergency department on their

16 own, visiting a physician on their own, and then

17 the poison center receiving a call from that

18 healthcare professional, and that's the way it's

19 documented.

20 So, in summary, about nine to ten

21 thousand exposures, on average a year, over this

22 eight year period of time -- most of the exposures

27 1 occurred in small children, 97% were

2 unintentional, and about 98% had no affect or only

3 a minor affect, so relative safety from that

4 standpoint.

5 Only two single substance fatalities --

6 and again, unfortunately I don't have more

7 detailed information to provide to you. There

8 could have been other substances involved somehow

9 that weren't identified.

10 Ninety-five percent were treated without

11 a healthcare facility referral, and there's

12 overall very low morbidity and mortality

13 associated with at least the calls that are

14 retrieved and managed by poison centers.

15 And then the final slide -- again, these

16 are the annual reports as presented -- or as

17 published by the American Association of Poison

18 Control Centers. And again, if you go to

19 AAPCC.org, look under National Poison Data System,

20 it's all available on the front part of their web

21 page.

22 So, with that I conclude my remarks.

28 1 Thank you very much for your kind attention.

2 DR. WHYTE: Thank you. And now we'll

3 have five minutes of questions, if we have any

4 questions or follow-up.

5 DR. LOSTRITTO: Thank you.

6 Interesting presentation. I know you said that

7 the details of the data are limited, but in your

8 experience, do you have any indication if any of

9 the moderate or even minor affects that you were

10 seeing in these exposures to homeopathic products

11 could be due to the quality of the excipients

12 used, or to some aspect of the manufacturing

13 process?

14 MR. KRENZOLOK: And I wish I had an

15 answer for you. Thank you very much. As -- what

16 we do -- and some of these calls may have been

17 misrepresented. They may or may not have been

18 homeopathic calls, too.

19 All of the data for manufacturers are

20 submitted to the poison -- it's Micromedics (ph) -

21 - which is the database the poison centers use.

22 Each substance has a unique seven digit code, and

29 1 therefore, that seven digit code -- when the

2 poison information specialist receives a call

3 about product "xyz," they put that code in for the

4 medical record and it goes into it. And so they

5 may not realize there's a homeopathic product

6 even. There may not even be full product

7 disclosure.

8 So, in my experience, I would say that

9 there are limited data available on the

10 composition of a lot of these products, and so I

11 don't have a better answer than that.

12 Thank you.

13 DR. NELSON: Thank you. Let me follow

14 that up with a clarifying question. Given the

15 process you just described, are you -- what's the

16 accuracy of the reporting of it being a

17 homeopathic product as opposed to some other type

18 of product that might not be a prescription

19 pharmaceutical?

20 MR. KRENZELOK: Um --

21 DR. NELSON: Can I just follow-up?

22 MR. KRENZELOK: Yeah.

30 1 DR. NELSON: And I wonder how much of

2 the trend towards younger children is just based

3 on reporting and parental concern for that age

4 group, as opposed to, you know, to the older

5 children that might still ingest it, but they just

6 wouldn't call.

7 MR. KRENZELOK: Sure. The first

8 question, accuracy, all of the data,

9 unfortunately, that comes into poison centers --

10 you know, we're not out there in the home and

11 taking a look at -- this is the bottle, this is

12 the actual substance they ingested -- and so

13 accuracy is a relative thing, but it's relative to

14 all products, whether they're homeopathic or

15 whether they're OTC or prescription

16 pharmaceuticals.

17 And then with regard to pediatric

18 exposures, I was sort of quizzical about that

19 myself and why there are more pediatric exposures,

20 and the only rationale I can come up with is that

21 perhaps there are few of the homeopathic products

22 that have child resistant closures on them,

31 1 therefore giving greater access to children then

2 say a conventional pharmaceutical agent may have

3 that's like an acetaminophen product or aspirin,

4 or something like that that's in a child resistant

5 closure.

6 DR. IZEM: I have a question about the

7 trends over time in what you showed -- is the data

8 aggregated over the whole time period? Did you

9 notice a change over time?

10 MR. KRENZELOK: There was a change over

11 time. You notice it started off kind of slowly,

12 and it peaked, and then it crescendoed, and then

13 it went down, and those numbers more or less

14 parallel call volume at poison centers, and what

15 we've seen, experienced, at poison centers over

16 the last few years is a decrease in call volume

17 because of a greater alliance of people on the

18 internet and parents searching out answers on

19 their own without calling the poison center.

20 That's our opinion, anyway, as to why those

21 numbers are going down. So they really parallel

22 actual poison center exposure numbers.

32 1 DR. IZEM: Another question is, in your

2 report, do you separate between OTC versus

3 prescription in either "homeopathic" or "all

4 pharmaceuticals" categories?

5 MR. KRENZELOK: No. And the AAPC data

6 cannot separate and distinguish between OTC and

7 prescription because they're not a separate code

8 that identifies OTC versus prescription.

9 So -- as a matter of fact, we were

10 looking for those data, and I said it's just

11 impossible to really obtain those data, unless you

12 took, perhaps, a single substance, something like

13 antacids, for example, and compared homeopathic

14 products against antacids, or some class -- known

15 class of non-prescription drugs.

16 MR. PACE: You're presenting two kind of

17 classifications of pharmaceutical products with

18 different volumes of use. Can you clarify how

19 these rates may compare to compliment the raw

20 numbers in terms of, you, 80,000? Does that

21 represent a certain percent of the total kind of

22 homeopathic product use?

33 1 MR. KRENZELOK: Well, those 80,000 are

2 the homeopathic exposures, and I don't know what

3 that is from a market share standpoint or

4 anything. I'm sorry, I just -- I'm familiar with

5 the poison center data -- if that's what you were

6 getting at.

7 DR. BENT: And can you help us

8 differentiate between the definitions of minor,

9 moderate, and major affects, and do you use the

10 same definitions for the homeopathic products and

11 other exposures?

12 MR. KRENZELOK: That's great, and I

13 meant to explain those and I apologize for not

14 doing that.

15 So, no affect speaks for itself. Minor

16 affect is a self-limiting affect. You know, maybe

17 a little irritation, an episode of, you know, eye

18 irritation or something of that nature. A

19 moderate affect is usually a bit more sustained

20 and it may be -- a minor affect might be vomiting

21 that occurred once. Moderate affect might be

22 multiple episodes of vomiting, and generally

34 1 moderate effects are those that persist up to

2 eight hours.

3 Major affects are disfiguring or life

4 threatening, and that's the very clear definition

5 of that. And then fatality speaks for itself.

6 DR. WHYTE: That will be the last

7 question. Thank you.

8 MR. KRENZELOK: Thank you very much.

9 DR. WHYTE: We are -- despite what I

10 told you about this timer up here, we are having a

11 technical timer issue, so we might have to go old

12 school and use our watches, so we'll see.

13 And I apologize in advance if I

14 pronounced -- if I pronounce your name wrong. Mr.

15 Krenzelok and I had an opportunity to meet, so I

16 tested it out. So I apologize if it doesn't work.

17 So maybe we'll wait a second to see if

18 our timer is back functioning. That looks better,

19 although it's -- can we reset? So I beg your

20 indulgence for a minute.

21 I did get a note that some folks on the

22 webcast are having difficulty hearing, so -- I

35 1 mean, I thought it was going well, so I do ask

2 that you all clearly speak into the mic. And they

3 did point out, especially on the part of our

4 panelists, to make sure that you talk clearly into

5 the mic so they can also hear.

6 So, it looks like the timer is resent,

7 and hopefully it will work this time, but I'll use

8 my watch as well to ensure fairness, and with

9 that, I'm delighted to introduce our next speaker,

10 Adriane Fugh-Berman from the Georgetown University

11 Medical Center.

12 MS. FUGH-BERMAN: Good morning. I'm

13 Adriane Fugh-Berman. I'm an Associate Professor

14 in the Department of Pharmacology and Physiology

15 and the Department of Family Medicine at

16 Georgetown University Medical Center, where I

17 teach about medicinal plants, dietary supplements,

18 and evidence based medicine. I also direct

19 PharmedOut, which is a project that promotes

20 rational prescribing.

21 I have no commercial conflicts of

22 interest, but I'm a paid expert witness in

36 1 litigation regarding pharmaceutical marketing

2 practices.

3 I've authored two books on complimentary

4 medicine. I wrote the first chapter on

5 complimentary medicine in Harrison's (ph)

6 "Principles of Internal Medicine," and I've worked

7 for the Office of Alternative Medicine, which is

8 now known as the National Center for Complimentary

9 and Integrative Health.

10 Between 1998 and 2012, I was also a

11 consultant for the Federal Trade Commission on

12 dietary supplements.

13 I'm concerned about the current state of

14 labeling for homeopathic remedies, particularly

15 OTC preparations. Although the FDA has increased

16 its focus on the safety, quality, and claims,

17 regarding dietary supplements, the Agency has

18 continued to defer its regulatory oversight of

19 homeopathic drugs.

20 Now, in the U.S. we practice -- in the

21 U.S., both classical homeopathy and homeopathic

22 polypharmacy are practiced and the sequestered

37 1 racks of individual homeopathic remedies that are

2 ordered or compounded by prescription and

3 administered by those with specialized knowledge

4 have not and should not be of regulatory concern.

5 What I'm most concerned about is the

6 stocking of homeopathic remedies that are labeled

7 for specific symptoms or conditions that are

8 alongside conventional OTC drugs in the pharmacy,

9 or on supermarket shelves.

10 This is innately misleading. Most

11 consumers have no idea what homeopathy is and they

12 may assume that these products or dietary

13 supplements are even conventional drugs.

14 Consumers, and probably most healthcare

15 professionals, are unaware that the FDA does not

16 review homeopathic drugs for safety or efficacy,

17 and while homeopathic drugs are supposed to comply

18 with federal requirements for good manufacturing

19 practices, it's my understanding that the FDA does

20 not routinely review these products for identity,

21 purity, potency, quality, or stability, prior to

22 marketing.

38 1 It's generally believed that homeopathic

2 drugs are completely safe because they're highly

3 diluted. From a homeopathic perspective, less

4 diluted remedies are less potent and more diluted

5 remedies are more potent, thus high potency or

6 prescription homeopathic remedies represent the

7 most dilute forms, and these can be considered

8 safe because any homeopathic preparation diluted

9 to 30x or beyond -- that's 30/10 to one dilutions

10 -- is unlikely to have even a single molecule of

11 the original substance left in it.

12 However, most over the counter

13 homeopathic remedies are low potency preparations

14 because they're not highly diluted. These

15 preparations may contain measurable and

16 pharmacologically active levels of ingredients.

17 For example, Cold-EEZE contains 13.3

18 milligrams of zinc per lozenge. At recommended

19 six lozenges a day, that's about 80 milligrams of

20 zinc a day, or ten times the RDA for adult

21 females, or eight times the RDA for males.

22 A similar OTC cold remedy, Zicam, states

39 1 that each lozenge contains zincum aceticum and

2 zincum gluconicum at 2x, which represents a

3 dilution of one to 100, or 1% concentration.

4 What consumer or healthcare professional

5 knows what this nomenclature or dose information

6 means? In this case the drug label provides no

7 useful information to the average consumer or

8 clinician, and those who can interpret the

9 concentration still won't know how many milligrams

10 of zinc are in this product.

11 Although zinc is an essential element,

12 excessive zinc can suppress copper and iron

13 absorption and cause other toxic effects.

14 Since any ingredient with a homeopathic

15 proving, that is listed in the homeopathic

16 pharmacopeia of the U.S., qualifies as a

17 homeopathic ingredient, homeopathic remedies can

18 contain snake venom, heavy metals, controlled

19 substances, glandular extracts, and other

20 ingredients that would be considered potentially

21 unsafe by usual drug standards. Even more

22 concerning are companies that sell homeopathic

40 1 preparations containing prescription drugs.

2 For example, Guna Interleukin Remedies

3 contains several interleukins and alpha

4 interferon. These are prescription drugs that are

5 approved only for serious conditions. Each has

6 significant label warnings and precautions.

7 The homeopathic OTC version is labeled

8 for chronic pain relief, anti-inflammatory, good

9 for auto-immune. Guna Interleukin 12 is

10 advertised for anti-allergy immune support,

11 asthma, COPD, and bronchitis. The dangers of

12 selling prescription drugs as homeopathic remedies

13 are obvious.

14 It's misleading to sell homeopathic

15 remedies alongside conventional OTC drugs.

16 Allowing homeopathic remedies to sit side by side

17 with conventional drugs that have undergone FDA

18 scrutiny as over the counter drugs is inherently

19 misleading.

20 Consumers may assume that these

21 homeopathic products or phitomedicines (ph)

22 medicines are dietary supplements, and not only do

41 1 these homeopathic remedies undergo none of the FDA

2 review that conventional drugs are subject to, but

3 they're not even regulated to the extent that

4 dietary supplements are regulated.

5 Disease claims are disallowed for

6 dietary supplements, but homeopathic remedies can

7 make the same disease treatment claims as

8 conventional drugs.

9 Perhaps homeopathic remedies should be

10 sequestered from other remedies and sold under a

11 banner or label that explains what homeopathy is,

12 with enough information so that a consumer can

13 make an educated decision about purchasing a

14 remedy that may contain no active compounds.

15 The evidence for homeopathy's

16 effectiveness is between scant and nil. This

17 picture has become much more clear over the past

18 20 years. Although there are some positive trials

19 of homeopathy, the benefits tend to disappear when

20 trial analysis is limited to high quality trials.

21 Just this year an assessment of 176

22 studies and 57 systematic reviews from Australia's

42 1 National Health and Medical Research Council,

2 concluded that there are no health conditions for

3 which there is reliable evidence that homeopathy

4 is effective.

5 The inclusion of the homeopathic

6 pharmacopeia of the U.S. and the Food, Drug, and

7 Cosmetic Act of 1938, is often considered a

8 concession to Senator Royal Copeland, a Surgeon

9 and homeopathic physician.

10 But the FDA's own historian, Suzanne

11 Junod, has pointed out that that explanation is

12 actually pretty simplistic. At the time,

13 homeopathy was practiced by many physicians. The

14 medical profession was not hostile to the

15 practice. There were more homeopathic physicians

16 in the AMA than there were in the American

17 Institute of Homeopathy.

18 Junod suggests that the inclusion of a

19 physician prescribed class of therapies was an

20 effort to combat fraudulent therapies that were

21 widely sold. While physicians could be held to a

22 code of ethics, charlatans could not. Perhaps the

43 1 belief that homeopathy was a dying specialty also

2 played a role in the AMA's passivity at the time.

3 In 1972, the FDA decided to exclude

4 homeopathic products from FDA drug review. The

5 market was considered trivial. The products

6 lacked safety concerns, and once again, homeopathy

7 was considered a dying specialty.

8 The reports of homeopathy's demise,

9 however, has been greatly exaggerated.

10 Ironically, the presence of quack remedies on the

11 market may have contributed to the inclusion of

12 the homeopathic pharmacopeia in the 1938 Act.

13 We need to invoke that spirit once more.

14 Homeopathic remedies should have to disclose their

15 ingredients using modern nomenclature and standard

16 dosing terms.

17 The FDA must reconsider its deferral of

18 regulation over homeopathic drugs. All OTC

19 preparations should have disclose ingredients on

20 the label and how much of each active ingredient

21 they contain.

22 I propose the following recommendations

44 1 in order to improve the OTC homeopathic drug

2 label:

3 All active ingredients should be listed

4 using modern chemical scientific language, as FDA

5 currently requires for drugs, foods, and dietary

6 supplements.

7 For plant products, Latin binomial

8 nomenclature, common name, and plant part, should

9 be included.

10 All inactive ingredients should be

11 listed using the same principles as required for

12 conventional drugs.

13 Ingredient quantities should be

14 expressed in standard, scientific format. E.g.,

15 micrograms for tablet, milligrams for milliliter,

16 etcetera, not just homeopathic dilution formats.

17 And any use or indication that would

18 fall under prescription status should be submitted

19 under a new drug application and be reviewed and

20 approved by FDA for product consistency and

21 quality, safety and efficacy, using standard study

22 designs, prior to being marketed in the United

45 1 States.

2 If the FDA decides to continue its

3 deferral of regulatory oversight on homeopathic

4 remedies, it's strongly recommended that a

5 disclaimer be added to the OTC homeopathic remedy

6 label to the effect, "This product is a

7 homeopathic remedy. As such, it has not undergone

8 review or approval by the FDA, and therefore has

9 not been documented to be safe or effective to

10 diagnose, treat, prevent, mitigate, or cure, any

11 condition or disease."

12 To date, the lack of regulation of

13 homeopathy has depended on its safety, but it is

14 not safe to have mislabeled, misleading products

15 on the shelves.

16 Thank you.

17 DR. WHYTE: Thank you. Let's restart

18 the timer at five minutes, if we can, and we'll

19 start our questions.

20 MS. LIPPMANN: Hi. You provide some

21 good, helpful detail about the recommendations you

22 have for what the labels should contain for these

46 1 products. Do you have an opinion about whether

2 there should be information in those labels about

3 what homeopathy is, what it's based on?

4 MS. FUGH-BERMAN: Yes. Either that or

5 having them in a sequestered area where there

6 actually is an explanation of what homeopathy is.

7 It's very confusing to consumers the way that it

8 is now. They don't understand what homeopathy is.

9 DR. LOSTRITTO: Yes. Thank you. I want

10 to come back to a fundamental labeling issue, and

11 you mentioned that products like Zicam and others

12 are labeled as homeopathic.

13 And I wanted to ask you if you know

14 whether you -- or whether you consider that to be

15 a problem associated with the way conventional

16 over the counter products are allowed to be

17 labeled, or is it a problem associated with the

18 way homeopathic over the counter products are

19 labeled?

20 In other words, is that something that

21 should not have appeared on those over the counter

22 products containing functional levels of zinc?

47 1 MS. FUGH-BERMAN: Right. So certainly

2 there are homeopathic products on the market that

3 contain as much of a particular substance that a

4 dietary supplement would contain, but my

5 understanding of the law is that it can be sold as

6 a homeopathic substance -- a homeopathic drug --

7 if the substance is in the U.S. homeopathic

8 pharmacopeia. So even if something is

9 pharmacologically active, it can still be sold as

10 a homeopathic drug.

11 So, for example, with plant products,

12 the homeopathic dilution starts with a mother

13 tincture, which is an herbal tincture that will

14 have pharmacologic levels of an herb in it. That

15 is then diluted into -- diluted many times -- but

16 the mother tincture is still considered a

17 homeopathic product.

18 So, apparently zinc and other compounds

19 can be considered a homeopathic product, even if

20 it has not yet been richly diluted.

21 MR. PACE: You spoke a little bit about

22 the differences in high and low potency

48 1 homeopathic products. Can you comment on a

2 potential distinction in policy between the low

3 and high potency products? I mean, do you think

4 there should be one?

5 MS. FUGH-BERMAN: Well, in classical

6 homeopathy, where you're fitting somebody's

7 symptoms and personality, if you will, onto a

8 specific high potency homeopathic product that may

9 be even prescribed by a prescription from somebody

10 who's trained in this, there does not seem to be a

11 safety concern with those individual products.

12 So that's an interesting idea, making a

13 distinction between them. So the high potency,

14 more dilute products would be less likely to cause

15 problems. But I think that really they should all

16 be labeled.

17 If it's a high potency product, you

18 know, we can say, "This product has less than .01

19 nannograms" of a particular ingredient in it.

20 DR. BENT: Could you comment a little

21 on the variability of the pharmacologically active

22 substances in low dilution products?

49 1 MS. FUGH-BERMAN: The variability of

2 what?

3 DR. BENT: The variability of the

4 pharmacologically active substance in the highly -

5 - or in the high and the low dilution products.

6 MS. FUGH-BERMAN: So if a product is 1x,

7 that means it's been diluted ten times once. If

8 it's 3x, it's been diluted three times. If it's

9 3c, it means it's been diluted a hundred times,

10 three times, so it's a hundred to the third.

11 So, by the time you've diluted something

12 30 times, even in a one to ten, the chances -- you

13 might be below Avogadro's number at that point, so

14 you probably won't have any molecules of the

15 original substance left in it.

16 MR. PACE: And when you speak about

17 listing quantity, would those products essentially

18 list zero?

19 MS. FUGH-BERMAN: Well, there certainly

20 should be a designation that is, you know, less

21 than -- less than .01 nannograms, or something

22 like that. Yeah. I think it would -- because it

50 1 would be difficult to -- it would be difficult,

2 you know, to test it for exactly how much was in

3 it, but if it's a high dilution, it should say,

4 less than some very, very tiny number.

5 I think that would give more information

6 to consumers, and also healthcare providers.

7 Thank you.

8 DR. WHYTE: Okay. Next we will turn to

9 Michael DeDora from the Center for Inquiry -- or

10 is it Inquiry?

11 MR. DeDORA: Thank you. I speak today

12 as Director of Public Policy for the Center for

13 Inquiry, an educational and advocacy organization

14 that promotes reason and science in public

15 affairs.

16 My testimony, however, is not on behalf

17 of only our organization, its employees, and its

18 members, but also on behalf of dozens of doctors

19 and scientists associated with CFI and its

20 affiliate program, the Committee for Skeptical

21 Inquiry with whom we work on these matters.

22 Neither I nor the Center for Inquiry has any

51 1 financial interest relevant to these matters.

2 We applaud the Food and Drug

3 Administration for holding this important meeting.

4 Given the tremendous growth in the sale of

5 homeopathic products in recent decades, a

6 reassessment of the FDA's regulation of these

7 products is clearly warranted.

8 Our goal is to briefly review the

9 scientific evidence that shows homeopathy is an

10 ineffective method to treat illnesses, illustrate

11 the harm caused by reliance on homeopathy instead

12 of actual medicine, and to propose actions the FDA

13 should take to hold homeopathic products to the

14 same standards as non homeopathic drugs in order

15 to fulfill its mandate to protect the American

16 public.

17 We could spend hours discussing the

18 extensive, decades long, scientific examination of

19 homeopathy, but suffice it to say, the empirical

20 evidence against homeopathy is overwhelming.

21 Aside from the placebo effect,

22 homeopathic products have no effect in treating

52 1 illnesses.

2 Consider, for example, the most recent

3 findings released last month by the Australian

4 National Health and Medical Research Council.

5 This group conducted a meta study thoroughly

6 assessing more than 1,800 papers on homeopathy,

7 225 of which met the criteria for inclusion.

8 They conclude that, "There are no health

9 conditions for which there is reliable evidence

10 that homeopathy is effective."

11 Of course, this makes sense. By its own

12 definition, homeopathy cannot work. It's

13 centuries old principals sit at complete odds with

14 our modern understanding of biology, chemistry,

15 and physics -- the bodies of accepted knowledge

16 that form the basis of modern medicine.

17 Again, we need not spend much time on

18 this, as the federal government is well aware of

19 the scientific evidence against homeopathy.

20 As the National Center for Complimentary

21 and Integrative Medicine states on its website,

22 "There is little evidence to support homeopathy as

53 1 an effective treatment for any specific

2 condition."

3 Furthermore, the FDA itself has

4 recognized that homeopathy is not effective

5 through its varies consumer warnings about the

6 health risks of relying on homeopathic products to

7 treat medical conditions. This includes the FDA's

8 March 19, 2015 warning against using homeopathic

9 products that claim to treat asthma, an often life

10 threatening condition.

11 Despite substantial empirical evidence

12 to the contrary, companies persist in marketing

13 ineffective homeopathic products as drugs that can

14 effectively treat illnesses, and consumers

15 continue to spend upwards of billions of dollars

16 each year believing that they will be helped. And

17 worse, even if these products might not be

18 effective, they are at the very least not harmful.

19 This should deeply concern the Agency

20 charged with protecting public health, especially

21 as the problem is in part caused by set Agency's

22 failure to regulate homeopathic products. Despite

54 1 what many consumers believe, homeopathic products

2 can directly cause harm. Sadly, children often

3 bear the brunt of this harm.

4 For instance, in its 2012 report, the

5 American Association of Poison Control Centers

6 noted that there were a whopping 10,311 reported

7 cases of exposure related to homeopathic agents,

8 with 8,788 of those reported cases attributed to

9 children five years of age or younger. Of those

10 cases, 697 required treatment in a healthcare

11 facility.

12 Still, perhaps the greatest harm caused

13 by homeopathy is not necessarily caused by the

14 products themselves, which when properly prepared

15 rarely contain anything other than water and

16 inactive ingredients, such as sugars and binding

17 agents, but by the fact that people often rely on

18 homeopathic products to the exclusion of proven

19 scientific remedies.

20 As the Australian study states, "People

21 who choose homeopathy may put their health at risk

22 if they reject or delay treatments for which there

55 1 is good evidence for safety and effectiveness."

2 The website "What's The Harm" details

3 many such cases. I will highlight just a few.

4 Lucille Craven of New Hampshire was diagnosed in

5 1997 with a small pea sized carcinomas breast

6 tumor. Although her doctor recommended

7 mastectomy and lumpectomy, Lucille treated her

8 cancer with homeopathy. She died less than 36

9 months later.

10 Diane Picha (ph) of Wisconsin was

11 diagnosed in late 1998 with lung cancer. After

12 successful surgery to remove her tumor, her cancer

13 grew back. Picha (ph) visited a homeopathic

14 clinic where she was advised to halt further

15 treatments. She died in April 2000.

16 Katie Ross of Nevada was diagnosed with

17 ulcerative colitis. Doctors recommended that she

18 have her colon removed. However, her mother

19 pursued homeopathic treatments. Katie dwindled

20 from 90 to 50 pounds and nearly died when her

21 colon perforated, but survived when her mother

22 finally approved surgery at the doctor's pleading.

56 1 Lastly, Isabella Dinley (ph) of

2 Melbourne, Australia, was an epileptic toddler

3 prescribed anti-convulsent medication by her

4 Neurologist. Her parents, however, treated her

5 exclusively with homeopathic products. She died

6 at just 13 months old.

7 These examples clearly illustrate the

8 public's lack of knowledge regarding homeopathy,

9 the danger of homeopathic products, and thus, the

10 need for the FDA to take an active approach in

11 promoting accurate knowledge on homeopathy.

12 Proponents of homeopathy often argue

13 that homeopathic products should be available

14 because individuals have the right to freedom of

15 choice. We fully support the right to freedom of

16 choice, however, we also believe that true freedom

17 of choice is impossible unless one is fully

18 informed on the choices.

19 In fact, this is one of the fundamental

20 principles justifying FDA regulation. The public

21 needs the guidance of an expert agency when it

22 comes to buying drugs.

57 1 Accordingly, we propose that the FDA

2 announce and implement strict guidelines that

3 require all homeopathic products to meet the same

4 standards as non homeopathic drugs.

5 In particular, we suggest the FDA take

6 three steps. One, testing for homeopathic

7 products -- as the FDA recognizes, the Federal

8 Food, Drug, and Cosmetic Act does not exempt

9 homeopathic products from meeting the same

10 standards of safety and efficacy as non

11 homeopathic drugs, nor does this Act prevent the

12 FDA from enforcing these standards.

13 In order to protect the public health,

14 we urge the FDA to mandate that all homeopathic

15 products on the market pass safety and efficacy

16 tests equivalent to those required of non

17 homeopathic drugs on the market.

18 Two, labeling for homeopathic products.

19 Labeling on homeopathic products needs to improve.

20 This is especially true if the FDA does not

21 require that they be tested for safety and

22 efficacy, as this would allow dangerous

58 1 homeopathic products to remain on the market

2 without warning, marketed to a public that is

3 unaware homeopathic products are different in kind

4 from non homeopathic drugs.

5 Currently, many homeopathic products

6 boast that they are regulated by the FDA without

7 explaining that they are not subject to testing.

8 This is seriously misleading.

9 We, therefore, urge the FDA to ensure

10 that all homeopathic products prominently state

11 two things. One, the products claimed active

12 ingredients, in plain English, and two, that the

13 product has not been evaluated by the FDA for

14 either safety of effectiveness.

15 Third, regular consumer warnings. We've

16 been encouraged by the FDA's recent announcements

17 warning consumers that homeopathic products will

18 not treat their illnesses.

19 Given the lack of public knowledge on

20 homeopathy, we urge the FDA to continue making

21 such announcements on a regular basis, especially,

22 but not only, during times of illness outbreaks

59 1 and public health crises.

2 In summary, homeopathy is unsupported by

3 scientific evidence, ineffective in treating

4 illnesses, and when relied upon instead of actual

5 medicine, dangerous and even deadly.

6 To ensure the protection of the American

7 public, the FDA should rely on its well

8 established regulatory system to require

9 homeopathic products to meet the same standards as

10 non homeopathic drugs, or at the least, mandate

11 labeling for homeopathic products which states the

12 products claimed active ingredients in plain

13 English, that the product has not been evaluated

14 by the FDA for safety or effectiveness.

15 The American public deserves as much

16 from the Agency tasked in protecting them. Thank

17 you.

18 DR. WHYTE: All right. We can reset the

19 timer for five minutes, and if we have any

20 questions for Mr. DeDora from the Center for

21 Inquiry?

22 MS. LIPPMANN: Yes. Do you have any

60 1 data or information you can share with us about

2 the effectiveness of disclaimers in ensuring

3 consumer understanding generally and how that

4 might relate to homeopathic products?

5 MR. DeDORA: I think that's a fantastic

6 question. I don't have any data that I can think

7 of off the top of my head, but if it exists we

8 will be sure to include it in our written comments

9 that will be submitted later.

10 MS. LIPPMANN: Please do. Thanks.

11 MR. DeDORA: Thank you.

12 DR. LOSTRITTO: Hi. I was just

13 wondering if the Center for Inquiry, along the

14 commission of, you know, scientific elucidation,

15 has looked at the manufacturing methods or the

16 ingredient quality that's typically used in these

17 products, or if not?

18 MR. DeDORA: We, through our magazine,

19 Skeptical Inquirer, have done a number of reports

20 by doctors and scientists regarding the process by

21 which homeopathic products are made.

22 I think some of the comments that were

61 1 made in the remarks before me highlighted that

2 problematically sometimes some things can get into

3 these products that shouldn't be in there and can

4 cause some health risks.

5 I'm not, unfortunately, well versed on

6 that specific area -- on this topic though -- and

7 again, it's something that I think we could

8 follow- up in our lengthier written comments.

9 MS. MICHELE: You commented that you are

10 requesting that all homeopathic products on the

11 market pass safety and effectiveness testing

12 equivalent to those required for non homeopathic

13 drugs.

14 So are you proposing that these products

15 be required to be tested, but still marketed under

16 enforcement discretion, such that the FDA would

17 not review those tests? Or are you proposing that

18 all of these products would come in under a new

19 drug application, as with other over the counter

20 and RX products that are not subject to the OTC

21 monogram?

22 MR. DeDORA: If I understand your

62 1 question correctly, the way that we read the Food,

2 Drug, and Cosmetic Act is that currently the FDA

3 does have the authority to require homeopathic

4 products to pass the same tests as other non

5 homeopathic drugs on the market.

6 So, we're not sure that there needs to

7 be new legislative or other authority taken by the

8 Agency. I'm not sure if that's what your question

9 was about though.

10 MS. MICHELE: No, that's actually not

11 what I'm asking. So, you're asking about this

12 type of testing -- so are you suggesting that

13 these should fall under the same new drug

14 application regulatory pathway as other drug

15 products?

16 MR. DeDORA: Yes. Thank you.

17 DR. WHYTE: Okay. With that we will now

18 turn to Wayne B. Jonas, the President and CEO of

19 Samueli Institute. Did I say that correctly?

20 MR. JONAS: Yes.

21 DR. WHYTE: Okay.

22 MR. JONAS: Good morning. How are you?

63 1 I think I'm the bridge here.

2 Thank you very much for having me and

3 giving me a few minutes to summarize the evidence

4 for homeopathy. I'm not going to talk about

5 labeling, but I'm really going to address what

6 research do we know? What does it mean? Where

7 are we in the state of research around homeopathy

8 -- identify some of the gaps, and hopefully shine

9 a light on why there is so much controversy around

10 these areas, and is there any evidence that there

11 should be controversy in those areas.

12 So, I am a physician and I run an

13 organization called the Samueli Institute. It's a

14 nonprofit, independently funded, research

15 organization.

16 We're interested in a variety of aspects

17 of non pharmacological approaches to healing, and

18 do research from basic science all the way up to

19 health services research, and I have no conflicts

20 of interest in this. We're not funded by any

21 company of any type, nor am I an expert witness

22 for anybody.

64 1 So, I'm a family physician -- 35 years -

2 - 24 years of that in the military. During that

3 time I directed the Medical Research Fellowship at

4 Walter Reed Army Institute of Research, where I

5 taught research methods to physicians, and we

6 continue to do that at Samueli Institute as well

7 as other healthcare practitioners.

8 I also ran the NIH Office of Alternative

9 Medicine and homeopathy was one of the several

10 hundred types of practices we were charged with

11 trying to sort out the truth from the falsities,

12 and come up with the diversity of research methods

13 necessary.

14 I ran the WHO Traditional Medicine

15 Center, and I'm also currently a Professor of

16 Family Medicine at Georgetown and at the Uniform

17 Services University.

18 So I got interested in homeopathy when I

19 was running a clinic in Germany as a military

20 physician, and the German physicians that I had to

21 work with for our emergency transport were using

22 homeopathy regularly and claiming that it worked

65 1 quite well, and that they could integrate it with

2 their conventional care.

3 So I became very curious about that,

4 especially since it didn't look like there was

5 anything in them, and began to try it out in my

6 own practice and then subsequently try to look at

7 the research to see what evidence there was in

8 those areas.

9 So, I and my colleagues, German

10 colleagues and others, published the first med

11 analysis, clinical med analysis, of homeopathy in

12 the Lancet in 1997, and we also published the

13 first laboratory med analysis of homeopathy in

14 1994, and then subsequently published the first

15 attempt to sort of look at the specific

16 indications and what evidence do we have around

17 its usefulness in particular clinical conditions

18 in the Anals (ph) of Internal Medicine in 2003.

19 When I retired from the military in 2001

20 and started the Samueli Institute, we continued to

21 work -- about half of our time is with DODVA (ph)

22 and other university labs. We do all of our

66 1 research by finding the best quality scientists

2 around the world and then trying to set up teams,

3 and then funding those projects to make sure that

4 they're done rigorously.

5 We currently have several projects in

6 the field of homeopathy. We focus mostly on

7 laboratory research because that sort of gets at

8 this issue of the ingredient and the placebo

9 issue. So animal models, cell models, this type

10 of thing, and now have ongoing programs looking at

11 brain injury in laboratory and cell models,

12 defense agents, cancer, viral infection, and

13 environmental toxicology.

14 I won't have time to go over that

15 research with you, but it is available if -- and

16 most of it is published in journals if you'd like

17 to see them.

18 But let me just make a comment about

19 what research quality is. Good research is when

20 you match the question and the people that are

21 going to use the information that you get out of

22 the research, with high quality methodologies.

67 1 And so there's no one single methodology

2 that is superior to all others. You have to match

3 it with a question. You have to know who is going

4 to use it.

5 So you have to first ask the question,

6 and this is the Methods Mandala that I've used for

7 years in teaching research methods to folks, and

8 it starts -- and if you look in the ring -- let's

9 see, right in the middle there -- those are the

10 sort of main questions that people ask.

11 What is it and how is it applied?

12 What's the current evidence for it? What impact

13 is it having in a particular session? How does it

14 work? Is it safe and effective? What does it

15 cost? How does it compare to other systems? Very

16 important recently with comparative effective

17 research that's gotten popular -- and then how can

18 it be translated to other practices?

19 These are the fundamental questions that

20 primarily biomedical research asks, and around the

21 outside ring are examples of methodologies that

22 are used to try to get that information.

68 1 And so when you look -- when you talk

2 about high quality, it's important to make sure

3 you know you're using the right method for the

4 right question.

5 As illustrated by this cartoon, "You

6 know it's wrong -- maybe it's just unorthodox,"

7 you don't use unorthodox methodologies to get at

8 the truth. You have to use good science in these

9 areas. But those who don't know science, who are

10 not very well educated in this kind of

11 methodology, often misapply methodologies to try

12 to make statements that weren't meant to answer

13 the question in the beginning. And so this is

14 kind of category error is something that you have

15 to pay attention to.

16 So, in any of these methods you try to

17 get at something called validity, which is --

18 there's a variety of types of that. Here's an

19 example of different types of validity:

20 Internal validity, which is trying to

21 get at the efficacy question. Is the effect

22 actually due to what you think it is, your

69 1 hypothesis? External validity, which is looking

2 at, you know, is this something that's real and

3 replicable out in the real world? Model validity,

4 which is, have you actually applied the approach

5 the way it adequately -- in order to actually test

6 it adequately?

7 There's other types of validity, but

8 they all are focused on trying to reduce bias and

9 improve our judgment management. It doesn't do

10 too much good to do a very rigorous study and then

11 just have someone dismiss it without actually

12 looking at the methods in those areas, which

13 unfortunately is what happens too often.

14 So, if we take these research standards

15 and then we just sort of do a broad brush of the

16 current research in homeopathy, the approaches

17 that one can look at for some of these questions

18 are systematic reviews and randomized controlled

19 trials for looking at efficacy, longitudinal

20 outcomes research for getting at effectiveness,

21 and laboratory research for getting at mechanisms

22 in those areas.

70 1 In all of these cases, as I've

2 illustrated, it's very important to minimize bias,

3 and the bias reduction techniques that have been

4 developed over the last ten to -- ten years,

5 especially -- have markedly improved, but

6 unfortunately, most people don't apply that.

7 And we have developed and systematized,

8 and streamlined some of these systems. We call

9 them REAL and SEARCH processes -- applied a lot of

10 these to controversial areas to try to sort out

11 the wheat from the chaff.

12 We also use things like the GRADE

13 analysis and work closely with the Rand

14 Corporation. We actually have a chair and a

15 program, a joint program, at Rand in Santa Monica,

16 which looks at management of judgment issues

17 around science using approaches called

18 "appropriateness," which goes into the next step

19 in terms of looking at -- once you have the

20 evidence, how do you make determinations of what's

21 an appropriate practice and what's not? And

22 that's a whole process for doing that.

71 1 So, I want to step back and do a -- talk

2 about meta-analyses (ph,) because it's a little --

3 it's instructive in terms of what's happened over

4 the last several decades.

5 This is the title of the Lancet med-

6 analysis that we published in 1997, and I'd just

7 point out that it did involve experts from the

8 Cochrane Collaboration, now -- more well known now

9 than it was back then -- and also Larry Hedges.

10 Larry Hedges is a Professor at the

11 University of Chicago, who literally wrote the

12 book on meta-analyses. It has all kind of really

13 interesting techniques for trying to find out if

14 your own methods that you're using are biased,

15 because sometimes those are hidden.

16 So, that meta-analyses took 98 studies at

17 that time in homeopathy, clinical trials,

18 randomized placebo control trials, and did a whole

19 series of attempts at getting at, you know, could

20 you get rid of the effect, if you saw an effect,

21 beyond placebo, in those areas?

22 And so we did a whole series of

72 1 sensitivity analyses, including the high quality

2 components. We did something called the "worst

3 case" which is like applying all of the quality

4 components one could ever come up with to those

5 areas, and then we did subgroup analyses for

6 different types of homeopathy.

7 And this graph actually illustrates in a

8 single thing what we found. If it's on that side,

9 it favored homeopathy. If it's on this side it

10 favored placebo. And as you can see, the vast

11 majority of these things seemed to favor

12 homeopathy.

13 We had tried to eliminate that effect,

14 but we couldn't. We got close. We actually got

15 very close, so we said, "Well, maybe it just is

16 because of what's in the literature." There's

17 something called publication bias.

18 We know in meta-analyses positive studies

19 tend to get published more often than negative

20 studies, and so maybe that's what was going on.

21 So we did a funnel plot like this, and

22 we found out at that time that indeed positive

73 1 studies were more in the literature than the

2 negative studies, and it looked like there was a

3 file drawer effect, that some of the negative

4 studies were just shuffled off.

5 Now, since this, it's been shown that

6 there's also reverse discrimination against

7 homeopathy, where positive studies tend not to get

8 in the top peer review journals that everybody

9 looks for, and that's been systematically

10 demonstrated by sending out peer review, changing

11 the labels, and finding out if you call it

12 homeopathy, the top journals won't publish it.

13 We sent our meta-analyses to many, many,

14 top journals before we could get it published in

15 the Lancet and it's still a problem in those

16 areas.

17 But Larry Hedges came up with a very

18 ingenious approach, which at that time was novel.

19 He said, "Well, what if you could estimate the

20 effects of the negative studies that were out

21 there somewhere, or might be out there some time

22 in the future, that would be required to eliminate

74 1 this effect?"

2 And so we did something called the "trim

3 and fill." You can do this mathematically. This

4 is a graphical illustration of that, and if you

5 did have no publication bias in these areas -- and

6 you could set different sensitivities for that --

7 could you eliminate this effect? We could get it

8 almost to zero, but we couldn't quite eliminate

9 it.

10 But, the lesson that we learned from

11 this, that we said in the article -- and we made a

12 prediction actually -- that all subsequent

13 systematic reviews, if they're attempting to

14 answer the large question of whether homeopathy

15 works or not, you're not going to be able to

16 answer it.

17 All it's going to be is just one

18 selection bias after another, depending upon what

19 studies you pick out to put in your study, and we

20 showed that mathematically. We estimated there

21 was not nearly enough investment in research in

22 homeopathy to ever, ever answer that question in

75 1 the next 100 years, unless a marked amounts of

2 money, more money, went into research in those

3 particular areas.

4 And so, if you look at the last couple

5 of decades of systematic reviews in these areas,

6 this is exactly what you see. These are the major

7 systematic reviews or meta-analyses done from 1991

8 until the Australian one, which was mentioned

9 already a couple of times this morning.

10 And, as you can see, it's exactly that.

11 One picks certain studies and says, gee, it's

12 positive, the other picks other studies, and says,

13 gee, it's negative, and you just sort of alternate

14 back and forth in these areas.

15 The latest one doesn't necessarily mean

16 it's the best one. In fact, the Australian study

17 was very poorly done if you use standard

18 systematic approach processes in those areas.

19 It's not the best study that's out there.

20 But this simply illustrates the

21 prediction that we made in 1997 around those

22 areas, that you can't answer that question. It's

76 1 almost like saying, "Well, gee, does surgery

2 work?" Okay? So we'd have to look at all studies

3 of surgery and, you know, put them together.

4 You've got to be more discriminatory on

5 that and that means you have to select out

6 specific treatments for specific conditions, and

7 then do the kind of meta-analyses that you're

8 looking for around those treatments.

9 Here's one that actually was not

10 mentioned in the Australian study. In fact, they

11 missed three systematic reviews even though they

12 claimed to have everything in those areas. But it

13 shows you an example in a specific condition, like

14 arthritis, what the current state of the evidence

15 is around the efficacy of homeopathy.

16 We attempted to do this in an Annuals of

17 Internal Medicine article. That was in 2003. It

18 needs to be updated. My best guess, and this has

19 not been updated so don't take any of the fault --

20 the next slide is the gold standard -- is that

21 right now the current evidence seems to indicate

22 that there are a variety of things, if you use

77 1 standard meta-analyses approaches, looking at two

2 or more randomized controlled placebo trails, that

3 it is effective for certain conditions, and using

4 the same criteria, that it's ineffective -- on the

5 right hand side.

6 I think if the FDA did anything, they

7 ought to actually invest in doing good assessment

8 of this literature using those kinds of --

9 investing and trying to sort out what we know.

10 Now, there's always the question of

11 replicability, and this is the problem. You do

12 studies over and over again, and they don't always

13 replicate itself.

14 Let me put that in context. Over the

15 last two years there's been a lot of discussions

16 about replicability, and it's not as easy as it

17 looks. Nature and JAMA (ph) both have published

18 extensive studies on that. John Iunodis (ph) from

19 Stanford University is probably the primary

20 scientist who's looked into these areas and he's

21 shown that even established studies, drug studies,

22 over 40% of them cannot be replicated. These are,

78 1 again, peer reviewed publications.

2 We know in drug studies of

3 antidepressants, for example, it's very difficult

4 to show replication over a placebo, which is why

5 we spend hundreds of millions of dollars trying to

6 get them approved and show that they actually work

7 better than placebo in those areas. Psychological

8 and behavioral sciences are worse.

9 So, given my time is running down here,

10 I'm going to talk a little bit about a comparative

11 effective research, which is a recent area that's

12 gotten attention. This allows whole systems to be

13 compared and it allows observational studies or

14 randomized studies to be used in those areas.

15 Here's the best long-term observational

16 study of homeopathy. It doesn't look at the

17 specific effects or the mechanistic effects in

18 those areas, but it does show overall, in over

19 3,000 patients, that if you go see a homephath,

20 regardless of what they're doing, you know, you

21 seem to get better, and that improvement seems to

22 persist in those areas.

79 1 The argument -- my last slide -- the

2 argument that you hear around the controversy is

3 because different people have different

4 hypotheses. The placebo hypothesis is what the

5 skeptics purport, and the other mechanisms that

6 are listed underneath here are ones that the

7 advocates support. There's very little data for

8 either of these hypothesis that isn't different

9 than what goes on in those areas.

10 So, I hope the FDA will actually do what

11 we just did for the DOD, and do a comprehensive,

12 systematic assessment of homeopathy for the

13 current evidence in these areas. We just

14 published this in Pain Medicine, looking at

15 integrative and non- pharmacological approaches to

16 pain. We're doing the same with the Rand

17 Corporation in Chiropractic right now, and that

18 kind of approach should be taken in homeopathy.

19 So, thank you.

20 DR. WHYTE: Thank you. And let's reset

21 the timer. You'll have five minutes for

22 questions.

80 1 MR. LOSTIRITTO: Hi. Very comprehensive

2 overview. I would ask you if you know if any of

3 these studies looked at the use of homeopathy in

4 conjunction with what would be considered more

5 conventional therapy, and any change in outcomes

6 from that?

7 MR. JONAS: Yeah. A number of those --

8 a number of them have. I didn't have a chance to

9 show sort of the equivalent studies where they

10 were looking at homeopathy compared to, let's say,

11 an established, on the market, OTC. There's been

12 examples of that, for example, for vertigo and

13 other things.

14 Again, there's even fewer studies in

15 that area than there are -- and equivalent studies

16 require very special power calculations to

17 actually show that they are equivalent. Most of

18 the studies in those areas have shown that the

19 homeopathic remedy has about equivalent to the

20 standard drug in those areas.

21 A recent one came out on depression that

22 actually added a placebo arm to that, which then

81 1 allows you to distinguish both of those. Very few

2 studies do that. Mostly they do that -- and if

3 all of them are getting improvement from the

4 placebo effect, then you don't know. Is it -- you

5 know, you just know that they're equal.

6 In comparative effectiveness research

7 they do quite a bit of that. I think you need to

8 actually add on treatment as usual, and/or a

9 placebo, in order to distinguish between those.

10 In comparative effectiveness research,

11 because of this phenomenon, they're going more and

12 more to costs, and saying, "Well, how much -- how

13 difficult is it to deliver and what does it cost,

14 and what are the side effects?" rather than trying

15 to answer the equivalence -- that equivalence

16 side. So I don't know if that answers your

17 question or not, but --

18 DR. IZEM: I have a question about your

19 main systematic reviews in meta-analyses that you

20 listed in one of your slides.

21 MR. JONAS: Yeah.

22 DR. IZEM: I was wondering, did these

82 1 different meta-analyses include the same set of

2 trials? Were they starting from the same set of

3 trials? And if yes, were the differences that were

4 observed in the different meta-analyses just driven

5 by different methodologies that were used?

6 MR. JONAS: So over the years there has

7 been a gradual increase in the number of studies

8 published, and so the ones in 1997 did not include

9 all the same ones in 2014, although usually they

10 try to build on themselves, so they did try to

11 capture what was there before, and so you got

12 incremental growth in those areas. Not always,

13 sometimes there was -- they didn't capture them

14 all.

15 The methodologies were not the same. In

16 fact, the selection criteria -- for example, in

17 the Australia study -- very different than what

18 was done in most meta-analyses, where they went in

19 and actually picked out what they considered the

20 top meta-analyses and then used their quality

21 assessments to make judgments, for example.

22 Most meta-analyses do an independent

83 1 quality assessment of that area, so there's an

2 example of two different kinds of methods that

3 were used. So the answer is, they don't use the

4 same method.

5 DR. IZEM: And some of the meta-analyses

6 that you mentioned put information from different

7 indications together, and also, was that true for

8 all of the systematic meta-analyses, or did they

9 restrict themselves to particular indications?

10 MR. JONAS: Most of them -- well, the

11 larger ones tried to catch -- who are trying to

12 answer the big question of homeopathy -- would try

13 to capture and then sub analyze the individual

14 ones.

15 Some of the meta-analyses preselected the

16 conditions they were looking at and then only

17 looked for studies in those areas, so they had a

18 much smaller subset of conditions.

19 DR. IZEM: So one last question.

20 MR. JONAS: Uh-huh?

21 DR. IZEM: Is it -- was most of the

22 homeopathic trials -- were they putting together

84 1 OTC as well as prescription, or was it all

2 prescription?

3 MR. JONAS: So, the prescription varies

4 depending upon what country you're in, and so

5 there was no distinction in most of these as to

6 whether they were OCT or prescription items. They

7 were just lumping them together based on

8 indications and based on condition.

9 DR. NELSON: I think you rightly point

10 out some of the difficulties in meta-analyses, but

11 let me ask, what data would you then argue ought

12 to be brought to bear on showing the safety and

13 effectiveness of homeopathic products for specific

14 conditions?

15 MR. JONAS: Well, I think -- you know,

16 we run systematic reviews all the time for

17 different groups, and the first thing we do is we

18 sit down and try to define, what question is it

19 that the sponsor or the client wants to answer?

20 And out of that, then you can go through

21 a set of selection criteria that will get at that

22 particular question. You have to do that first.

85 1 That allows you to determine what data

2 should be done, and then you have to do the bias

3 reduction approaches that I'm talking about. So

4 you have to apply bias reduction components on

5 those.

6 DR. NELSON: Let me follow-up with a

7 clarity question. I was asking what data ought to

8 be brought forward to show efficacy? That's the

9 question, and not what data one can get out of the

10 literature based on bias reduction of studies that

11 have already been performed.

12 MR. JONAS: I think if you're going to

13 try to show efficacy, and you're trying to test

14 whether the component within a homeopathic remedy

15 - - that's assuming one can figure out what that

16 is - - then you have to do -- I mean, we have a

17 gold standard for that. That's the randomized,

18 double blind, placebo controlled trial,

19 replicated, multi- center, preferably, if the

20 question is efficacy of the particular component

21 of the product.

22 If you're trying to get a comparative

86 1 effectiveness -- a question that was asked before

2 about, you know, how does this work compared to

3 some other system of medicine? Because homeopathy

4 is a whole system. It's not just a remedy.

5 Then, I think the gold standard is to do

6 also randomization because you can then start at

7 the same finish line, but you can't do it -- you

8 can't really do placebo very easily in that if

9 you're doing very, very different systems. If

10 they're both drug systems, you can put in double

11 dummy and other kinds of things to try to get at

12 that in those areas.

13 So, if you're trying to get at

14 effectiveness, what happens when you put it out

15 into practice? I showed you the study that I

16 think is the kind of gold standard for that.

17 That's longitudinal, observational, large-scale,

18 big data at observational trials.

19 DR. NELSON: Thank you.

20 MR. JONAS: Uh-huh.

21 DR. WHYTE: So I do know they are having

22 a few issues with sound on the webcast -- not from

87 1 the speakers -- but I asked my colleagues that are

2 the panelists -- I think what's happening is when

3 you're asking your questions you're being very

4 gentile and turning to the panelist, and actually

5 turning your face away from the mic, and I think

6 that's causing some of the issues in terms of the

7 sound.

8 So, if you could either talk straight

9 into the mic with your question and then turn, I

10 don't think anyone will get offended on the panel,

11 because they do want folks that are watching it

12 being able to hear the questions and the

13 discussion.

14 We do have one more speaker before

15 lunch. That is Lisa Amerine from the Homeopathic

16 Academy of Naturopathic Physicians.

17 DR. AMERINE: One more before break.

18 Thank you for the opportunity to speak today at

19 this public hearing. My name is Dr. Lisa Amerine.

20 I'm a Naturopathic Physician, and am board

21 certified by the Homeopathic Academy of

22 Naturopathic Physicians, with Diplomat status in

88 1 homeopathy.

2 Since a very young age my life has been

3 committed to homeopathy, being raised using that,

4 and for the past 11 years I've maintained a highly

5 successful practice exclusively in homeopathy in

6 Lafayette, Colorado.

7 Currently, I also sit on the board for

8 the HANP. I am the HANP House of Delegates

9 representation for the American Association of

10 Naturopathic Physicians, in which I represent the

11 specialty field of homeopathy.

12 I am also a co-leader on what is known

13 as the Materia Medica Pura Project, a collective

14 30,000 plus hour project, with the purpose of

15 collecting any existing literature on homeopathic

16 medicine.

17 This literature includes proving

18 publications, toxicology reports, and cured cases,

19 for every homeopathic medicine. This information

20 is then compiled into one document known as the

21 Materia Medica Pura, and serves as the most up to

22 date information for homeopathic medicines. This

89 1 ongoing project ensures there is up to date and

2 correctly referenced literature on every

3 homeopathic medicine.

4 The Homeopathic Academy of Naturopathic

5 Physicians is a specialty field recognized within

6 Naturopathic medicine. Naturopathic physicians

7 lead our community throughout the U.S. in natural

8 healthcare.

9 Physicians who specialize in homeopathy

10 go over and beyond the already vigorous training

11 received in homeopathy at naturopathic schools, by

12 undergoing further training in homeopathy. Upon

13 completion of this process, which includes an

14 additional board examination, they are awarded a

15 diplomat status.

16 Practicing homeopathy is a true

17 specialty in medicine and a diplomat status

18 recognition rewards and acknowledges physicians

19 who have worked to achieve this status, setting

20 them apart from any others who may be practicing

21 homeopathy, thus naturopathic physicians with

22 diplomat status in homeopathy are among the

90 1 leading experts in the United States of

2 homeopathy.

3 The HANP also serves to further the

4 excellence and success of homeopathy by providing

5 continuing education to further sharpen the skills

6 of not only diplomats, but of other physicians

7 interested in homeopathy.

8 We are also committed to being an

9 education resource for general healthcare

10 providers and the general public who may have

11 questions regarding homeopathy.

12 So, the HANP would like to respond to

13 three particular questions posed by the FDA. The

14 first one is the question of the consumer health

15 care provider attitudes towards human drug and

16 biological products labeled as homeopathy.

17 The licensed homeopathic medical

18 professions have a vast knowledge of the Materia

19 Medica, which list the properties of medicines we

20 use.

21 This literature, when employed in

22 conjunction with consideration of the unique

91 1 totality of symptoms with which a patient

2 presents, forms the basis for the accurate

3 prescription of homeopathic medicines. Well

4 trained homeopaths will only prescribe based on

5 these principals.

6 Therefore, medicines labeled as

7 homeopathic, regardless of their source, including

8 human drug and biological products, will not be

9 prescribed unless there's proper literature found

10 in the monographs to support the prescription.

11 The homeopathic healthcare

12 professionals, especially those with diplomat

13 status, have very, very busy practices.

14 Frequently, we will train our patients regarding

15 homeopathic medicines that they can purchase over

16 the counter to take care of simple, non dangerous

17 conditions, such as an acute cold.

18 The consumers love this because they can

19 try some basic things at home that are often very

20 effective, very safe, and inexpensive to use. The

21 healthcare provider likes this because it empowers

22 the patient and leaves time for the physician to

92 1 treat more serious health conditions.

2 The next question is current areas --

3 are there areas of the current CPG that could

4 benefit from additional clarity? The HANP serves

5 to further the excellence of homeopathy by

6 providing a resource and continuing education for

7 providers in the community.

8 In an attempt to further the excellence

9 in homeopathy, the HANP believes that the FDA's

10 documentation, conditions under which homeopathic

11 drugs may be marketed, does need some

12 clarification.

13 For example, definition number two

14 states, "Drug products containing ingredients in

15 combination with non homeopathic active

16 ingredients are not homeopathic drug products."

17 While this definition is clear, there's

18 a loophole that many products are taking advantage

19 of. This loophole provides manufacturers the

20 opportunity to put a substance in the inactive

21 category list that would -- leaving the active

22 category list as HPUS (ph) homeopathic remedies

93 1 that clearly meets the definition.

2 These inactive ingredients are not

3 always stabilizers, but often a dietary supplement

4 or herb, for example, such as tea tree oil or Aloe

5 Vera. This allows manufacturers to put products

6 on the market and make an OTC drug claim when

7 otherwise their product would be limited to a

8 dietary supplement status.

9 When this is done, the product should

10 not be considered a homeopathic drug, nor should

11 they be allowed to be marketed as such. The HANP

12 believes this is a good example of where

13 additional clarification would be helpful.

14 The last question, do consumers and

15 healthcare providers have adequate information to

16 make informed decisions about drug products

17 labeled as homeopathic?

18 The Homeopathic Academy of Naturopathic

19 Physicians serves to provide quality education,

20 not only to other healthcare professionals, but

21 also to the lay public. Physicians, in particular

22 those with diplomat status, are in the front lines

94 1 of homeopathic healthcare, and daily field

2 questions from the consumer and from other

3 healthcare providers regarding homeopathic

4 products.

5 Every week I get people call us about a

6 product. What do you think about this? Is this

7 product safe? What can you tell me about this

8 product?

9 These experts, because of our knowledge

10 - - the extensive knowledge in homeopathy -- we

11 can easily provide information regarding products

12 which are labeled as homeopathic, and comment

13 knowledgeably as to the efficacy and safety.

14 However, I stated earlier there are many

15 healthcare providers and consumers who know very

16 little about homeopathy. As it's our goal within

17 the HANP to be able to provide these people with

18 quality information, we have a suggestion in terms

19 of -- for the HANP suggestion -- is to maintain a

20 team within the FDA that consists of experts in

21 drug regulation, the representatives of the

22 American Association of Homeopathic Pharmacists,

95 1 the American Pharmacopeia Convention of the United

2 States, as well as an expert clinical physician

3 who's on the front lines, who's practicing

4 homeopathy and fielding these questions daily to

5 help better this team.

6 A team comprised of such experts in the

7 field is vital and will be able to help clarify

8 any questions as to homeopathic labeling, and most

9 importantly, to ensure the safety of the

10 consumers.

11 In closing today, I want to end with a

12 story. One hundred and fifty years ago, on a

13 journey across the country -- the Oregon Trail --

14 a group of explorers got stuck in the Cascade

15 Mountains because of bad weather.

16 They had to abandon their wagons, and in

17 the process they chose to bury their most valuable

18 possessions. So when the weather -- when the

19 conditions were more favorable they could return

20 to get them. Amongst these things buried, there

21 was a small book written by homeopathic physician,

22 Constantine Hering, titled The Homeopathic

96 1 Domestic Physician, and a small homeopathic

2 medicine kit.

3 For these people, and people since then,

4 homeopathic medicines have been effective and safe

5 to use at home if their condition was not intense

6 enough to need attention, but -- or was intense

7 enough to need attention at home, but not sever

8 enough to seek the care of a physician.

9 There are many books such as this book

10 that still guide the consumers and the lay public

11 about making informed decisions regarding drug

12 products labeled as homeopathic.

13 Because homeopathy is safe and it's

14 fairly easy for the consumer to understand what to

15 buy should they have minor health ailments, the

16 HANP highly encourages that these homeopathic

17 medicines continue to be available over the

18 counter because they are so effective in helping

19 improve the health of the population.

20 Thank you so much for your time and

21 consideration.

22 DR. WHYTE: Thank you, Lisa. And we'll

97 1 have five minutes of questions. The timer is

2 already set, and we'll start with Dr. Nelson.

3 DR. NELSON: Two quick questions. I'm

4 curious if this Materia Medica Pura will be a

5 collation of the data or is there an intent to

6 provide a critical evaluation of the data that

7 exists?

8 And the second question is -- I was

9 struck by your final comment about self limited

10 illness and noticed the previous speaker had

11 rheumatoid arthritis, for example, on his list,

12 and it seemed that you were giving a much more

13 narrow focus of where homeopathy may have a place.

14 I wondered if you could comment.

15 MS. AMERINE: Sure. So, the first

16 question in regards to the Materia Medica Pura is

17 it's really just a collective data, so we collect

18 all of the data that we can find in any literature

19 that would be in existence for homeopathic

20 medicine, and we compile it into one location, so

21 then we can go back and look and see, you know,

22 what was this case? Or what were the toxicology

98 1 reports or the provings? Or the way that in

2 homeopathy we find the indications of a homeopathy

3 medicine. So it's all collected in one source.

4 The second question, if I understand the

5 question correctly, is in regards to -- like the

6 previous person was mentioning, rheumatoid

7 arthritis versus the common cold. This is where

8 the difference comes in between a specialty in --

9 a specialist in homeopathy who is practicing

10 homeopathy as a physician, who understands the

11 disease, versus something that's over the counter.

12 I think if -- a simple condition like an

13 acute cold, if there's something that's -- that is

14 like an acute cold or some acute condition -- an

15 injury that doesn't need some care -- a sting of

16 an animal or a bruise -- you fell -- or something

17 of that sort. I think it's great, at home, over

18 the counter.

19 When we cross the line into some of

20 these more diagnostic or more severe illnesses -

21 rheumatoid arthritis, other autoimmune diseases --

22 I really think that it's important to have

99 1 somebody who really understands medicine,

2 understands the prognosis of disease, so then you

3 can understand, is what we're treating what we

4 would expect, or is the disease pathology going on

5 as if nothing is being treated? Because if that's

6 the case, we need to address that and do what's

7 appropriate for the patient.

8 MS. LIPPMANN: Do you think your

9 patients understand what homeopathy is, the

10 mechanism by which it purports to work? For

11 example, the dilutions, the concept of like treats

12 like, the provings?

13 Do your patients understand that? And I

14 would ask the same about over the counter. Do you

15 think that the general public, who might go into a

16 CVS and purchase an over the counter homeopathic

17 product, do you have a sense that they have that

18 understanding?

19 DR. AMERINE: Sure. A lot of times when

20 they come into my practice they don't know. They

21 know that I do natural medicine. They want

22 something else. They know that I -- they have

100 1 these questions, and they don't know, so I have to

2 give a lot of time on education for them, and

3 explain to them what homeopathy is, and explain

4 the dilution series. I always explain that to all

5 of my patients.

6 The question about the consumer --

7 there's a lot of confusion in the general

8 practitioner, or in the general consumer world,

9 and you get all kinds of questions, all kinds of

10 different pronunciations, you name it, and it

11 comes in.

12 So they don't really have a good idea.

13 They see something labeled as homeopathic, and

14 they have no idea if they can -- to distinguish

15 something like Arnica Montana for bruising, versus

16 some combination piece that actually has some

17 inactive ingredients that are actually serving as

18 the active ingredient to make it.

19 They don't know the difference of that,

20 and so I work really hard to educate people in my

21 direct practice, but that's a small amount

22 compared to the vast consumers.

101 1 And so, I think that clarifying that

2 out, or having some boundaries around that better

3 would be a good idea.

4 DR. BENT: I'm interested in some of the

5 data sources that you have that would allow us to

6 understand purity and the effect of safety that

7 would feed into your compendium of information.

8 Do you have a surveillance protocol or how are you

9 coming up with information about the ingredients,

10 about the supply, about the purity?

11 DR. AMERINE: In terms of the over the

12 counter combination? Like what remedies are in

13 there?

14 DR. BENT: No, for any of them. It's

15 actually -- the actual supply chain for the

16 medicines that you're making.

17 DR. AMERINE: Sure. Well, if I

18 understand the question correctly, the way that we

19 know originally is we gather proving symptoms --

20 so we know the effects of the medicine in a

21 healthy person.

22 All of that data is collected, and we

102 1 collect all of that, but that's not enough by

2 itself. So then we need to see what happens when

3 somebody who is ill takes something of this?

4 So, we have the collection of all of the

5 data together in our proving, or we get them in

6 toxicology reports. We know that if somebody

7 overdoses on something -- what happens if a

8 healthy person takes too much -- this information.

9 So, when we then are applying it -- so

10 that's what a foundation is, and then we have to

11 rely on the principle of homeopathy, that we're

12 prescribing a medicine that would cause symptoms

13 if the person didn't already have those symptoms.

14 DR. BENT: I actually want to clarify.

15 I'm not -- I was thinking more about the specific

16 ingredients used in the manufacturing of the

17 product.

18 So you have the toxicology reports, but

19 do you have other data that talks about the purity

20 and the safety of the product?

21 DR. AMERINE: Really, other than that,

22 that's kind of our foundation, where we go for --

103 1 as far as I understand the question. Yeah.

2 DR. LOSTRITTO: Briefly. I see we're

3 close to out of time. I want to follow-up on that

4 question.

5 For the Materia Medica Pura project, I'd

6 like to ask you if you are also collecting data,

7 not only on the purity of the ingredients, the

8 excipients (ph) as well as the actives that are

9 diluted, but also on the manufacturing process,

10 which we know varies by dilution approach, by

11 succession methodology, and so forth.

12 Is this important information being

13 gathered? If yes, great. If no, why not?

14 DR. AMERINE: It is important

15 information being gathered because different

16 amounts of any product will cause different

17 varying of kind of symptoms, so that is included

18 into all of that.

19 So we'll collect information. If

20 somebody has taken something that's been diluted,

21 you know, one to 30 dilution, or 30c, or if

22 somebody took it in a crude dose, or if someone

104 1 took it further down diluted.

2 We collect all of that because we want

3 to see what happens when something is taken --

4 when medicine is taken by a healthy person, what

5 symptoms occur at different stages.

6 DR. WHYTE: Brad, did you have a

7 question?

8 MR. PACE: Yeah. Generally speaking,

9 how does a homeopathic practitioner decide on what

10 route of administration to use when they're

11 treating patients, and are there, you know, any

12 concerning routes of administration that you see

13 either on the OTC or prescription homeopathic drug

14 market?

15 DR. AMERINE: Sure. Generally the

16 homeopathic physician is going to prescribe

17 orally, either with little pellets that are

18 dissolved under the tongue, or with a medicine

19 that's been diluted into water a little bit and

20 they take it into water.

21 There's all kinds of routes of

22 administrations that I have seen, and to be

105 1 honest, there's not necessarily one way or another

2 that has laid out -- something I've thought about

3 a lot, is different administration routes -- is

4 something sprayed nasally? You know, is something

5 oral? Is it topical?

6 For the most part, I'm not -- depending

7 on the ingredient and the amount of the

8 ingredient, I'm not super concerned. Some of

9 these homeopathic products that are on the market

10 that are at a 1x or 2x dilution that are being

11 sprayed in the nasal cavity, for example, that has

12 potential to create some problems, so there's not

13 -- it's a tough question to answer because there's

14 a lot of "if this, then that."

15 Thank you.

16 DR. WHYTE: Well, thank you. So at this

17 point in time we're going to take a 15 minute

18 break. It is, according to my clock, 10:42, so we

19 will try to arrive back at around five of 11:00.

20 So, again, we'll take 15 minutes and we'll resume

21 at five of 11:00. Thank you.

22 (Off the record at approximately 10:42

106 1 a.m.)

2 (Recess.)

3 (Back on the record.)

4 DR. WHYTE: We'll get started at another

5 minute or two.

6 (Pause.)

7 DR. WHYTE: What we're talking about

8 here is, it turns out when the panelists -- more

9 than one of them -- put their mic on, it actually

10 cancels out the mic, so the people in the overflow

11 room as well as online, can't hear.

12 So what we're suggesting is maybe people

13 will put their tents sideways and that way

14 people's mics won't cancel out. And, you know,

15 it's actually hard for me to see down there when

16 people's lights are tents, so I'll allow all of

17 you to self police. You are all very cordial so

18 I'll do that.

19 So we're going to go ahead and get

20 started. We have a couple of speakers before our

21 lunch break, and I see Amy Rothenberg's notes

22 here, so in case -- okay, well good, you're here.

107 1 So if you weren't here I was going to present your

2 notes.

3 So we'll start off with Amy Rothenberg

4 from the American Association of Naturopathic

5 Physicians.

6 MS. ROTHENBERG: Thank you very much.

7 You probably would have done a really good job.

8 The writing was very big and clear, and hopefully

9 would be understandable by anybody.

10 Thank you for the opportunity to

11 present. My name is Amy Rothenberg. I represent

12 the American Association of Naturopathic

13 Physicians. I am also the President of the

14 Massachusetts Society of Naturopathic Doctors in

15 Massachusetts. I have no conflict of interest

16 whatsoever.

17 I am certified by the HANP that Dr.

18 Amerine spoke about just before the break. I also

19 sat on the Board of Health in Amherst,

20 Massachusetts for six years, bringing a natural

21 medicine perspective to the public health arena.

22 I recently stepped down as Vice

108 1 President of the Amherst Survival Center that

2 offers free medical care, food, and clothing to

3 people in need -- another public health interest

4 of mine.

5 The AANP is a national professional

6 organization representing 4,500 licensed

7 naturopathic doctors in this country. Our members

8 are physicians trained as experts in natural

9 medicine.

10 In the clinic we take comprehensive

11 patient histories from our patients. We do

12 appropriate physical exams as indicated. We -- in

13 the states where we're licensed. There are 20

14 states and municipalities that license

15 naturopathic physicians at this time.

16 We order laboratory tests and diagnostic

17 imaging, and other diagnostic tests, and like

18 medical colleagues, we diagnose and treat disease.

19 Naturopathic doctors work

20 collaboratively across all forms of medicine. I

21 often send out, both for support diagnostically

22 and treatment wise for my patients, when I need

109 1 help, and I also accept referrals from all

2 different kinds of doctors in my community and

3 even around the country.

4 We attend four years in residence, full-

5 time naturopathic medical school, post graduate,

6 and there are currently seven such schools in the

7 United States. Each are recognized by the

8 regional accrediting bodies and those

9 organizations are recognized by the Federal

10 Department of Education.

11 Our foundational work is equivalent to

12 that done by ND's and DO's in terms of the basic

13 sciences -- anatomy, physiology, biochemistry,

14 histology, etcetera -- and our systems review

15 classes as well. Things like radiology,

16 neurology, gynecology, immunology, dermatology,

17 pediatrics, etcetera.

18 In addition, naturopathic doctors study

19 - - the naturopathic approach is emphasizing both

20 disease prevention and lifestyle modification and

21 whole person wellness through therapeutic,

22 nutrition, botanical medicine, and homeopathy.

110 1 Degrees are awarded after extensive

2 classroom study and clinical training. In order

3 to be licensed to practice, the MD must also pass

4 extensive post-doctoral exams and fulfill annual

5 continuing education requirements.

6 We provide treatments that are safe and

7 effective, and we are extensively trained in

8 pharmacology so that we are kept abreast about

9 drug and nutrient interactions, drug herb

10 interactions, and the like, to try to keep our

11 patients as safe as possible. We work with

12 compounding pharmacists as well to ensure safe and

13 comprehensive care.

14 We have practiced and taught homeopathy

15 since naturopathic medicine was defined as a

16 profession. We have primary care providers fully

17 trained in homeopathic prescribing and integrating

18 homeopathy into our naturopathic school education,

19 out board examinations, and into our clinical

20 practices.

21 Aside from my current positions that I

22 mentioned, I also cofounded the New England School

111 1 of Homeopathy with my husband, Paul Herscue (ph)

2 who is another naturopathic doctor in Mass's

3 public health, one of the largest and oldest

4 continuous post graduate study program in

5 homeopathy in the United States, training

6 providers and physicians in the art and science of

7 homeopathy.

8 I've lectured extensively at places like

9 -- in homeopathy -- at the American Medical

10 Student Association, the American Holistic Nurses

11 Association, the Retail Clinicians Education

12 Congress, which has nurse practitioners and

13 pharmacists on board, at the University of

14 Massachusetts Medical School where they like to

15 trot me out periodically to talk about homeopathy

16 and natural medicine.

17 This is a fairly representative example

18 of naturopathic doctors and homeopathy in and

19 around this country at this point in time.

20 I would like to respond to two

21 particular questions posed by the FDA. The

22 question number one, what are consumer and

112 1 healthcare providers attitudes toward human drug

2 biological products labeled as homeopathics? And

3 again, I don't know if I said, but I have been in

4 private practice for 30 years just about -- coming

5 on 30 years.

6 Homeopathy is perceived favorably by

7 both naturopathic doctors and patients, both for

8 its efficacy, but particularly because of its

9 safety profile and its inexpensive cost, as well

10 as the quality of the product.

11 The consistency and quality are

12 preserved by the American Association of

13 Homeopathic Pharmacists, and the Homeopathic

14 Pharmacopeia of the United States, using the CGMP

15 (ph) -- and taught to physicians -- and over

16 decades of use, I have not personally found

17 problems with variability or the quality of

18 homeopathic products, or toxicity.

19 The experience of naturopathic

20 physicians who use homeopathic products is

21 consistent with other licensed physicians reports

22 of homeopathic use, specifically positive,

113 1 reliable results, with low toxicity, an affordable

2 and easy to administer, well tolerated product.

3 I'd like to address question number

4 four. Are there areas of the current CPG that

5 could benefit from additional clarity? If so,

6 please explain.

7 We believe -- the AANP believes that the

8 CPG Section 400.00, conditions under which

9 homeopathic drugs may be marketed -- is sufficient

10 as written. That said, we believe that

11 enforcement of those guidelines could be clarified

12 in collaboration with the American Association of

13 Homeopathic Pharmacists, the Homeopathic

14 Pharmacopeia, and the AANBP.

15 We've identified two particular areas

16 that reflect a need for further clarification or

17 compliance. The first one is CPG Section 400.00.

18 The definition states, "Drugs and products

19 containing ingredients in combination with non

20 homeopathic active ingredients are not homeopathic

21 drug products."

22 While the definition is clear and

114 1 appropriate and accurate, and I don't think it

2 needs to change, I think there could be more

3 robust enforcement here. We have found a number

4 of products that use several ingredients where the

5 homeopathic drug is only one part and the rest of

6 the active ingredients are not homeopathic.

7 The AANP agrees with the FDA that these

8 should not be marketed as homeopathic products,

9 and again, this comes back to labeling and care

10 and accuracy that needs to go into any labeling

11 that's done.

12 And the second point that I wanted to

13 make is that the CPG Section 400.00 background

14 states that those products that are offered for

15 treatment of serious conditions must be dispensed

16 under the care of a licensed practitioner.

17 People who suffer from potentially life

18 threatening illnesses or more chronic ailments

19 should be treated by healthcare providers, by

20 licensed healthcare providers.

21 Having over the counter drugs,

22 homeopathic or otherwise, labeled in a confusing

115 1 manner for consumers, should be avoided at all

2 cost. We urge that no homeopathic product be

3 labeled with any potentially life threatening

4 diseases, such as asthma, as a prominent feature.

5 While this is already in the guidelines

6 and need not change, it would be wise to build in

7 more interactions, just like this one, between the

8 FDA, the AAHP, the HPCUS, and the AANP, to clarify

9 best practices with regard to accurate labeling

10 guidelines.

11 That said, this potential is only --

12 this is only a hazard -- a potential hazard -- and

13 for me personally, in decades of teaching and

14 practicing and prescribing, caring for many

15 thousands of patients in my practice over the

16 years, I have not seen adverse effects. So we are

17 not seeking change in the current policy, only

18 further clarification and enforcement.

19 Of particular import is having properly

20 labeled homeopathic products stay over the counter

21 so they remain a choice for the public for self

22 care of self limiting problems, as talked about by

116 1 Dr. Amering.

2 The change that we are recommending is

3 more interaction between the FDA and these

4 organizations and to have better compliance.

5 I wanted to take a minute to share -- to

6 dovetail off of something that Dr. Jonas spoke

7 about earlier related to laboratory research on

8 mechanism and action with homeopathy. I had the

9 great and distinct pleasure of meeting Dr. Edward

10 Calabrese, who is a PhD researcher at UMASS in

11 Amherst, after he had published an article in

12 Toxicology in 2013 called Hometic Mechanisms From

13 Critical Reviews. I'm sorry, Hometic Mechanism --

14 the journal was Critical Reviews in Toxicology.

15 And he lays out his understanding of the

16 mechanisms that play in hormesis, which is defined

17 as a dose response phenomenon characterized by low

18 dose stimulation and high dose inhibition.

19 Historically, dose responses have been thought to

20 occur in a limited fashion from low to high dose.

21 A non-linear response, such as the

22 hermetic response, has potential application in

117 1 most every field in science. I think we could all

2 agree. His paper, and many, many others that he

3 has written, offer the first wide reaching

4 documentation of mechanisms -- of hermetic dose

5 concentration responses.

6 In his paper he wrote, and this is a

7 quote -- I don't write this eloquently -- so,

8 "Regardless of the model, in vitro or in vivo,

9 inducing agent input, or receptor cell similarly

10 pathway mediated mechanism, the quantitative

11 features of the hermetic dose concentration

12 responses are similar, suggesting that the

13 magnitude of the response is a measure of biologic

14 plasticity within a broad range of biological

15 context. These findings represent an important

16 advance in the understanding of the hermetic dose

17 concentration response, its generalizability, and

18 potential biomedical applications, including drug

19 discovery, efficacy assessment, and the risk

20 assessment process."

21 As a Professor of Toxicology at UMASS --

22 I live in Amherst, Massachusetts -- I decided I've

118 1 got to meet this guy. I've got to take him out

2 for lunch and just talk to him a little bit

3 because I feel like what he's proposing -- and his

4 studies are quite well done. He was awarded the

5 Mari Puri

6 (ph) prize in 2009 for his work on

7 homesis (ph.)

8 In any case, over the last 20 years he's conceived

9 and carried out hundreds of experiments to test

10 and reconfirm his findings. He continues his work

11 with both chemical toxins, radiation, drugs,

12 hormones, and other categories of molecules, on

13 cells, on plants, and on animals. Regardless of

14 the agents used, the organism exposed, the hometic

15 dose response was observed.

16 He shared with me his interest in dose

17 related response was first peaked in a biology

18 undergraduate class studying plant physiology.

19 While conducting an experiment using synthetic

20 growth inhibitor on peppermint plants, it was

21 observed that some plant growth was instead

22 stimulated, the opposite of what was expected.

119 1 His professor asked, "Anybody interested in

2 further study?" He was the only guy to raise his

3 hand.

4 As it turned out, the group had made a

5 dilutional error by a factor of ten. With very

6 low dose of growth inhibitor, plants grew more

7 than expected. At the higher doses of the growth

8 inhibitor, indeed the plant growth was stunted, as

9 predicted.

10 His advisor urged Calabrese to do many

11 more experiments to see if his observation was

12 real and reproducible. In experiment after

13 experiment after experiment over his long career,

14 the hometic results was observed.

15 So I only bring this up so that perhaps

16 if those of you on the panel are interested in

17 further study related to mechanism of action, this

18 might be a place to start. I would be happy to

19 put you in touch with Calabrese.

20 I did also want to share a personal

21 story. I'm going to switch hats here and share a

22 personal story about myself. You know, sometimes

120 1 the doctor is the doctor sitting in the doctor

2 seat, and sometimes the doctor has to move over --

3 bump over a couple of seats -- and sit in the

4 patient's seat.

5 Last year I was treated for breast and

6 ovarian cancer. Thank you for your prayers and

7 good wishes. I have an excellent prognosis and

8 I'm going to do very well.

9 I did every single thing that

10 conventional medical care could have offered, from

11 surgery to lots of chemotherapy, to radiation

12 treatments, and a few other things. I'm on

13 Tamoxifen. I probably will be for life.

14 That said, at every step of the way I

15 also used homeopathy, and sometimes that was over

16 the counter, sometimes that was by visiting with a

17 homeopathic physician, and all I can tell you is

18 that my providers -- and I was being treated at

19 Mass General with -- the head of every department

20 at Mass General -- I have a very interesting case,

21 apparently.

22 Every step of the way, what I was told

121 1 was, "Whatever you're doing, keep doing it." Some

2 people asked me what I was doing and I of course

3 was happy to share it, and I did write extensively

4 on the Huffington Post about my experience using

5 natural medicines, including homeopathy, alongside

6 conventional cancer care.

7 So, I just -- I'm bringing that up

8 because for me to be able to do my cancer care in

9 a way that was in harmony and in sync with my very

10 pristine lifestyle, my excellent diet, my use of

11 natural medicines, including homeopathy, was one

12 of the greatest gifts, both because I feel that I

13 was able to enhance the efficacy of conventional

14 care, I was able to reduce the side effects that I

15 might have experienced.

16 If I did have any side effects, I was

17 able to treat them early, quickly, and

18 effectively, and I was also able to really

19 maintain an excellent quality of life.

20 I mean, I had my -- my breast chemo was

21 in January and I feel like I look good, I sound

22 good, my brain is good, and I just feel like to

122 1 have access to natural medicines at times of need,

2 even when the disease is quite serious and life

3 threatening, is a right that we have in this

4 country, and I would really like to see that right

5 protected.

6 So, I think in conclusion I would just

7 like to circle back around. We feel the AANP

8 believes that the FDA's current regulatory

9 approach to homeopathic products is working well.

10 The low cost of the medicines as well as the

11 consistent quality of product make them appealing

12 to both physician and patient.

13 Over decades of use we have not found

14 problems or variability with the quality of

15 homeopathic products, and not much toxicity has

16 ever been reported.

17 They should remain available to the

18 public OTC. We do recommend certain

19 clarifications and closer working relationships

20 between the FDA, the AANP, AAHP, the HPCUS -- the

21 whole alphabet soup there.

22 Thank you very much for allowing us to

123 1 present these ideas.

2 DR. WHYTE: See, you didn't even need

3 your notes. You did well without them. And I'll

4 use the presiding officer's indulgence and thank

5 you for sharing your personal story. I know that

6 can be very hard to do in a professional and

7 public setting, so thank you for sharing your

8 story.

9 And my one question -=- we start the

10 time yet -- is did you get to go to the lunch?

11 Did he agree to lunch?

12 MS. ROTHENBERG: He did. He did. Thank

13 you.

14 DR. WHYTE: Okay. Good. All right.

15 We'll have five minutes on our clock and we'll

16 start our questions.

17 DR. LOSTRITTO: Yes. Thank you. I

18 wanted to ask you a clarifying question based on

19 your academic experience with the New England

20 School of Homeopathy, and also based on your

21 longstanding clinical practice.

22 In terms of prescription homeopathic

124 1 products, in your estimation what percentages of

2 them are commercially -- just transferred and

3 given to the patient from a commercial source that

4 somebody else makes them, versus a percentage that

5 is prescribed and compounded by a pharmacist?

6 And if you could clarify, because it's a

7 little -- it's a little unclear -- by compounding

8 pharmacist, do you mean any pharmacist or a

9 specifically trained homeopathic pharmacist?

10 MS. ROTHENBERG: When I made that

11 comment in my talk there I was talking about

12 compounding pharmacists outside of the realm of

13 homeopathy. There are a lot of naturopathic

14 physicians who work with compounding pharmacists,

15 perhaps on biodentical (ph) hormones.

16 My experience is I only use homeopathic

17 remedies that have been purchased or have my

18 patients purchase from recognized homeopathic

19 pharmacies, and I do believe that there are some

20 practitioners who might ask a homeopathic pharmacy

21 to create a homeopathic remedy for them from this

22 particular product.

125 1 I personally have never done that so I'm

2 not a good person to ask about that, but I -- that

3 is a great question and really, I was referring

4 more toward botanicals as opposed to -- and

5 hormone replacement -- as opposed to homeopathy.

6 MR. PACE: Um, this is kind of a general

7 question, but how would you define a homeopathic

8 product, and how can you ensure that the products

9 that you're using in your practice are prepared

10 according to the tenants of homeopathy?

11 MS. ROTHENBERG: I love that question.

12 Thank you very much. Our homeopathic pharmacies

13 are awesome and I have perfect faith in them. I

14 have to just say it like that.

15 I am not -- I cannot be -- I'm an expert

16 in a number of things. I cannot be an expert in

17 everything. I have left that job to the

18 homeopathic pharmacies, and I trust them and I

19 have faith in them, and I have just built my

20 career around that, and I don't waiver there.

21 I'm not interested in somebody in the

22 back room somewhere mixing up something and then

126 1 diluting it and shaking it. I'm not interested in

2 that. I want it coming from a reputable,

3 licensed, homeopathic pharmacy, and those are the

4 -- that's where we put all our faith, you know?

5 We really do.

6 I hope that doesn't sound, you know,

7 hokie, but that's -- I think there are a lot of

8 practitioners that, you know, they're not the

9 pharmacist and they're not the person making the

10 medicine, they're the person who is taking the

11 time to understand their patients in great detail

12 and prescribe for them an appropriate remedy for

13 them at that point in time. So -- yeah.

14 MR. PACE: How does that compare to what

15 is on the OTC drug market that are labeled as

16 homeopathic now?

17 MS. ROTHENBERG: Yes. I think that the

18 whole area of labeling is really at the heart of

19 this hearing, and I think that the things that are

20 labeled homeopathic that are just a single dose of

21 one remedy, that's what it would consider

22 homeopathic.

127 1 And so the things that are mixed up

2 together with other things, supplements, herbs,

3 that's not homeopathic. That's something else.

4 For something to be homeopathic, it has

5 to have been proven on healthy people. Healthy

6 people had to take it over and over and over

7 again, and then we -- they were watched to see

8 what kind of symptoms, if any -- if they were

9 sensitive to that product that they would be

10 reactive to and develop symptoms from, and then

11 those symptoms are collated and that is what we

12 use to prescribe upon.

13 So, if something has lots of different

14 things in it, it's kind of like poly pharmacy,

15 it's not homeopathy. It's something, it's not

16 homeopathy.

17 So, for me -- for it to be homeopathic

18 it has to just be the homeopathic remedy, and I

19 think labeling an accurate -- really being

20 sticklers around accurate labeling is central.

21 DR. NELSON: Thank you. If I could

22 follow up. You mentioned in your talk the

128 1 confidence you have in positive, reliable,

2 results, and I guess I'm curious -- separating out

3 the sort of proving -- and the single ingredient,

4 single dosage, just espoused -- how do you as a

5 practitioner then assess whether you've had

6 reliable, positive results when you've prescribed

7 one of these products?

8 MS. ROTHENBERG: That's a terrific

9 question. I personally really like outside,

10 objective, evidence. So if I can ever do anything

11 that's related to lab work, or related to the

12 assessments of other people with different

13 expertise than my own -- on a patient.

14 I'll give you an example. If I have a

15 child that I'm treating on the autistic spectrum,

16 and I'm using homeopathy with that family or that

17 child, I am not so much interested in the mom's

18 perception of how the child's doing, in terms of

19 you know, getting better at communicating, maybe

20 toileting, maybe learning the "ABC's," I'm

21 interested in their teacher's and their

22 therapist's reports because I fell like using

129 1 other people's assessment tools are very

2 important.

3 And as a physician, I think any

4 physician has ways of telling if their patient is

5 better. It hurts less, it bothers them less, it

6 itches them less, it's less annoying, their mind

7 is clearer, their sleep is better, their energy is

8 better.

9 I mean, these are all guideposts that

10 all doctors use, naturopathic doctors, medical

11 doctors, homeopathy, pharmaceuticals, it doesn't

12 matter. We want to see that our patients are

13 improving, and so we try to do that by asking good

14 questions, taking a very good, detailed history

15 initially, so that we can back and we can refer to

16 that. What were we trying to hit here?

17 And then, also, really being sure

18 whenever possible to use more objective ways of

19 figuring out if what we're doing if effective.

20 DR. WHYTE: Dr. Nelson says he has just

21 a little bitty follow-up.

22 DR. NELSON: A little follow-up. You

130 1 strike me as someone who uses a lot of tools in

2 giving your description.

3 So I'm curious, are you showing --

4 seeing these results as a result of only

5 prescribing homeopathic, or are you using all the

6 various tools that you have and then you see a

7 result? So can you actually attribute it to the

8 homeopathic product, or is it everything you do?

9 MS. ROTHENBERG: Thank you for that

10 question. I think that like a lot of

11 practitioners, we do what we need to do.

12 I have many patients for whom I only use

13 homeopathy because they have another naturopathic

14 doctor that they go to for everything else, and

15 they're just coming to me for homeopathy. I have

16 some patients who come to me who have no idea what

17 homeopathy is, and they really just want me to do

18 whatever I do.

19 And so the answer is, for some of the

20 patients, it's only homeopathy. In may practice

21 that's probably half of my patients, and for the

22 other half of my patients, it's things related to

131 1 therapy, nutrition, botanical medicine.

2 I do work with lifestyle modification

3 with all of my patients, and I think most

4 practitioners worth their weight in anything are

5 going to try to get people to, you know, eat

6 better, move more, do relaxation kind of

7 techniques, have good relationships. I mean,

8 these seem like the bread and butter of a good

9 practitioner.

10 But in terms of, who do I see that's

11 just homeopathy, and I think that their

12 improvement or their progress, or maybe their lack

13 of that, is due to just homeopathy, it's probably

14 about half of my practice.

15 Does that answer your question?

16 DR. NELSON: Yes.

17 MS. ROTHENBERG: Thank you very much.

18 DR. WHYTE: Thank you. And now we will

19 turn to Mr. Bruce Shelton -- Dr. Bruce Shelton,

20 excuse me -- from the Arizona Homeopathic and

21 Integrative Medical Association.

22 DR. SHELTON: Good morning, everyone.

132 1 My name is Dr. Bruce Shelton, MD, MDH. The MDH

2 means that I am licensed by the State of Arizona

3 to be a medical doctor, homeopath. Our state is

4 one of the three in the country that have such a

5 licensing board. The other two are Nevada and

6 Connecticut.

7 As such, our physicians in Arizona are

8 all graduates of MD and DO medical schools in the

9 United States. Oh, and I forgot to mention, I

10 earn the majority of my income from my private

11 practice in Phoenix and I'm a torturer of myself

12 for moonlighting. I work for homeopathic

13 manufacturers to teach other doctors how to use

14 products. I even helped develop some of them.

15 Okay?

16 We chose to answer this survey by

17 answering the questions that were posed by the

18 FDA, which we totally appreciate. Personally,

19 I've overseen 20,000 patient visits in practice

20 over the last 25 years since I became a

21 homeopathic, who have benefited from homeopathy.

22 It's critical to my personal success in helping

133 1 patients, particularly those who haven't been

2 helped elsewhere.

3 I have a truly complimentary practice.

4 There are definitely times where you need to use

5 regular drugs and there are times when

6 homeopathics are more appropriate, and our

7 profession allows the use of both, and my training

8 allows me to chose in between them. Okay.

9 I've never experienced in my practice

10 any safety or quality issues that warrant major

11 trouble. In my 25 years of practice with these

12 20,000 patient visits, I've had very few, if any,

13 material adverse events reported by my patients,

14 and have helped many recover from symptoms that

15 didn't respond to other types of medical care. I

16 see a lot of people that have been to other

17 doctors who couldn't help them.

18 There are almost 100 AHIMA, the Arizona

19 Homeopathic Integrated Medical Association,

20 practitioners who we estimate over the last 15

21 years have each seen 1,500 to 2,000 patient

22 visits, leading to a conservative estimate of

134 1 2,000,000 patient visits over this time period.

2 Now, I told you -- or I didn't tell you

3 - - I am the President of our licensing board.

4 I've served on it for about half of this time. We

5 only see three to six complaints a year on the

6 average from the public for adverse complaints,

7 none of which are ever related to the use of the

8 wrong homeopathic remedy.

9 We've seen complaints from doctors who

10 didn't pay their taxes and have gone to jail and

11 have been in danger of losing their licenses.

12 We've seen people allowing non-licensed

13 practitioners come in their offices, but the

14 majority of what we see at our board, where -- I'm

15 a regulator like all these nice people are, and we

16 help protect the public based upon the law that we

17 have in Arizona.

18 I understand it's a difficult job. I

19 don't envy you. I kind of, sort of, do the same

20 thing, and it's not easy sometimes. Okay.

21 The federal regulations are clear that

22 homeopathy should be available for use and

135 1 regulated under the HPUS guidelines. It's

2 important for practitioners to be able to choose

3 the appropriate medical path for their patients,

4 especially in non life threatening situations, and

5 in areas where other medical options have failed

6 their patients.

7 The next question -- of the other

8 countries, what do they do there regarding

9 homeopathy and what should we say about the FDA's

10 thinking in this area?

11 We found in our research that no major

12 organization, country, or government in the world

13 has determined that homeopathy isn't safe. All

14 major countries allow homeopathics to be used as

15 one of the many available medical therapies.

16 According to the World Health

17 Organization in a report they had entitled, Legal

18 Status of Traditional Medicine and Complimentary

19 Alternative Medicine, a World War Review, only the

20 country of Honduras does not allow the practice of

21 homeopathy along with all the other kinds of

22 complementary medicine. One country in the whole

136 1 word. Honduras. Don't go there -- go on vacation

2 and get sick. Sorry, Honduras. Never been there.

3 A homeopathy is recognized and utilized

4 as a system of medicine by most of the major

5 countries. The World Health Organization

6 published the 20 Top Ranked Healthcare Systems by

7 Country in the Year 2000, the latest year of a

8 report.

9 Of the top 20 countries worldwide, with

10 populations greater than 5,000,000, all 12 of the

11 top 20 countries on the list with populations

12 greater than 5,000,000 allow homeopathy to be

13 utilized. Nine of the 12 have officially

14 recognized homeopathy as a medical therapy.

15 Homeopathy is a material portion of the

16 medical systems in the countries throughout the

17 world that are considered first rate, such as

18 France, Germany, and Great Britain. Many doctors

19 in those countries use homeopathic therapies along

20 with non homeopathic drugs to a great effect.

21 France was rated the number one by the World

22 Health Organization.

137 1 In 1997 it recognized homeopathy as a

2 medical therapeutic method. Thirty nine percent

3 of French physicians have prescribed homeopathics.

4 Multiple French medical schools offer a degree in

5 homeopathy and all pharmacy schools in France

6 teach homeopathic courses.

7 According to the British Medical Journal

8 in the Netherlands, 40% of the general

9 practitioners use homeopathy.

10 A five year comprehensive review

11 completed by the Swiss government examined

12 efficacy, real world effectiveness,

13 appropriateness, safety, and economy of medical

14 therapies. The review found that the individual

15 CAM interventions, especially homeopathy, were

16 effective -- under Swiss conditions -- safe, and

17 far as could be judged from the trial situation --

18 also cost efficient.

19 Homeopathy is a major source of

20 healthcare in India. A recent Lancet paper says

21 that 100 million Indians use it as their sole

22 source of healthcare, and according to the Journal

138 1 Med India, there are 185 homeopathic colleges, and

2 11,000 homeopathic hospital beds.

3 Next question; are the policies of

4 enforcement under CPG appropriate to protect and

5 promote public health in light of the tremendous

6 growth in the homeopathic drug market?

7 In our opinion, there's no need to

8 change the guidelines. The public is currently

9 adequately protected by FDA regulatory authority.

10 The 400.400 CPG monograph totally outlines it and

11 the good companies that follow GMP practices do it

12 appropriately.

13 The Federal Trade Commission is there to

14 protect the public, and of course the legal

15 system, if there's ever a question. The FDA has

16 substantial regulatory authority right now to

17 ensure public safety. Homeopathics are

18 manufactured under strict GMP guidelines with the

19 homeopathic process as defined in the HBUS.

20 The current 400.400 provides substantial

21 guidance for the marketing of homeopathic

22 products. It effectively regulates all uses to

139 1 ensure safety, product quality, labeling

2 guidelines, and the OTC indications for the

3 majority of these products. It ensures

4 homepathics are not used for non OTC indications.

5 The FTC monitors the healthcare industry

6 regularly, including homeopathics, focusing on

7 issues such as false advertising and unreasonable

8 claims.

9 The FDA and the FTC regularly work

10 together, jointly when they have to, using the

11 regulatory power that they currently have to

12 educate consumers, ensure proper messaging and

13 marketing to provide public safety and awareness.

14 The next question, the OTC question --

15 the products available have a wide variety of

16 indications and many of these have never been

17 considered for OTC use under the formal process.

18 Okay. Homeopathic indications have

19 always been regulated through the HPUS, and other

20 accepted monographs and scientific data. Don't

21 forget, science in the homeopathic world is the

22 proving, which is really a study, and the Materia

140 1 Medica and the reparatory are the bibles that we

2 use in the homeopathic world to see if things are

3 fitting properly.

4 Any other regulation of indications

5 would mean that these substances would no longer

6 fall under the definition of a homeopathic.

7 Homeopathic principles, as directed by the HBUS,

8 dictate a specific method of determining correct

9 indications.

10 The current system of determining the

11 appropriate indications is fundamental and is a

12 core premise of homeopathy that has been safely

13 and effectively used since its inception.

14 The FDA has provided clear guidance that

15 OTC can only apply for conditions that a consumer

16 can self diagnose, self treat, and self manage.

17 Therefore, homeopathics are safe and appropriately

18 regulated for OTC conditions.

19 The FDA currently has ample regulatory

20 power to ensure that indications are appropriate

21 for OTC use. There's a clear standard for the FDA

22 to regulate current indications that fall outside

141 1 these guidelines for non prescription products.

2 The FDA already provides appropriate

3 guidance and enforcement. The FDA regularly

4 issues warning letters. Talk to anyone who's ever

5 received one -- what -- the fear it strikes in

6 their hearts -- has -- regularly issues warning

7 letters to manufacturers or sellers of

8 homeopathics that are promulgated indications that

9 are outside the realm. You either change or you

10 close your business. A lot of businesses have.

11 Do consumers and healthcare providers

12 have adequate information to make informed

13 decisions about drug products labeled as

14 homeopathic? If not, what information, including,

15 for example, information on labeling?

16 The current labeling and available

17 resources provide substantial information to

18 support use of homeopathic products when consumers

19 -- with consumers -- and inform them about use of

20 the products.

21 There are detailed labeling guidelines

22 that must be followed that are robust and

142 1 adequate. The indications provided are simple and

2 straightforward. The individual ingredient

3 information is readily available to the public

4 through multiple sources.

5 Healthcare providers have even greater

6 access to help them make informed patient

7 decisions. Doctors have access to textbooks,

8 educational courses, software programs, internet

9 compendiums, to provide further understanding of

10 homeopathics might best be used with an individual

11 patient.

12 In conclusion, therefore, homeopathics

13 are safe, effective, and crucial to our ability to

14 treat patients. The current regulatory structure

15 meets the needs of consumers and healthcare

16 providers, and ensures standards of quality by

17 homeopathic drug manufacturers. There are no need

18 for changes to the current regulations.

19 Thank you very much for letting me be

20 here.

21 DR. WHYTE: All right. Thank you, Dr.

22 Shelton. We now have five minutes of questions.

143 1 Let's start at the front, closest to me, and we'll

2 just run down the list. Now Kate threw it in at

3 the end, but let's start with Kate and then we'll

4 just go down the row.

5 MR. WU: Dr. Shelton, you mentioned that

6 interestingly there's only one nation in the

7 world, Honduras -- they don't allow the

8 homeotherapy. Could you elaborate a little bit for

9 the why this nation, they are not allowed to --

10 DR. SHELTON: To be honest with you, I

11 don't know why Honduras feels the way it does. We

12 gave the reference in the little handout that goes

13 with my notes and we can ask the World Health

14 Organization. I don't know.

15 MR. WU: And also related to that -- so

16 you also mentioned other examples of countries

17 like France and Swiss. So how these countries

18 evaluate -- I'll say the effectiveness of the home

19 therapy?

20 DR. SHELTON: Listen, it's my

21 understanding that the United States of America

22 went through a period known as the Flexner Report,

144 1 where homeopathy was thrown under the bus for

2 about 50 years, and the other countries never got

3 thrown under the bus, so they're ahead of us.

4 These countries are the home of where

5 Dr. Hahnemann lived. Dr. Hahnemann came from

6 Germany. He got remarried at the age of 80 to a 29

7 year old woman and moved to Paris where he

8 finished his life's work. He is buried in Paris.

9 I actually visited his monument here in

10 Washington yesterday. He's the only medical

11 doctor in the history of the United States that's

12 ever had a statue in Washington, and he never came

13 to this country.

14 The form of medicine in this country for

15 many years was homeopathy only, and the scientific

16 world of the drug companies helped stop the use of

17 it. We've woken up. We agree with it. We have

18 lived with it. But the people that use homeopathy

19 believe in it and it's coming back. The public

20 wants to have it.

21 I have a book with me right now. You

22 have no idea how many internet letters have come

145 1 with these hearings of people and patients who

2 don't want anything done to take their

3 homeopathics away from them. They actually fear

4 that this hearing itself is going to do something

5 bad, and we've tried to explain to them, "They're

6 just reviewing the regulations. They are supposed

7 to. They need to, and we agree with the proper

8 safety of the public. Don't go off the wall yet."

9 I hope that answers your question.

10 MR. PACE: You indicated that consumers

11 make informed decision about homeopathic drug

12 products. How do you define an informed choice

13 for a person walking down an OTC pharmacy drug

14 aisle?

15 DR. SHELTON: Well, there's a lot of

16 people that are very frustrated with the regular

17 system. I mean, that's -- the majority of the

18 people that I see in my office -- and I have a

19 medical office that still does all the charting

20 the way the government wants us to do it right

21 now.

22 I'm outside of the insurance industry,

146 1 which doesn't cover homeopathy. People are

2 willing to pay for it, they're so frustrated.

3 They walk down the aisle in the stores and they

4 see something labeled as homeopathic. They've

5 heard that it works. Maybe that might be the one

6 thing that you ought to be discussing, is how to

7 better clarify that.

8 But as far as I'm concerned, they're

9 looking for answers. This country is very

10 frustrated with the system as it currently exists,

11 and I'm sure you have to be aware of that, that

12 the change needs to be made in the education of

13 the public, that there are answers outside of the

14 current mainstream system.

15 DR. NELSON: So I'd like to just ask a

16 question of clarification of your argument. I

17 hope this is a simple answer, if I have it correct

18 or not. We'll see.

19 But I gather your argument about proving

20 and about the current regulatory process being

21 appropriate is that in fact once there is a

22 proving, that to require any other empirical

147 1 evidence beyond a proving that that product works

2 in any way would be inconsistent with the

3 principles of homeopathy, and would violate

4 therefore the homeopathic pharmacopeia. Did I

5 hear that right?

6 DR. SHELTON: Well, listen, there's no

7 reason not add more information and knowledge to

8 anything that we do in the world, but we shouldn't

9 make it onerous to the point that it would put the

10 existing things out of business.

11 A homeopathic proving is a very exacting

12 method of knowing what's going on. It's not done

13 in a test tube, it's done between two individuals,

14 the patient and the doctor that's treating them,

15 and adequately writing down what their symptoms

16 are, and you assume that the supervisor of the

17 proving is an honest person that can properly

18 distill the information that they get.

19 I mean, those things are really double

20 blind to some degree. I mean, they're double

21 blind completely and they work. And that's what

22 makes up the HPUS.

148 1 I mean, if you could -- if someone would

2 come along and win the Nobel Prize and tell us

3 what's actually happening in the energetic

4 solutions that we have, we're all in favor of

5 that. I'd like to volunteer to be part of writing

6 it up.

7 DR. WHYTE: Dr. Michele, do you have a

8 question?

9 DR. MICHELE: Yeah. So just to follow

10 up on that. Could you explain how the proving is

11 double blind in that you've got a practitioner and

12 you've got a patient, and they're writing it down?

13 So how is that double blind?

14 DR. SHELTON: There's three people

15 involved. There's a master supervisor that knows

16 what the proving is all about. The person who is

17 taking the symptoms from the patient is a

18 homeopath who doesn't know what the remedy was and

19 doesn't know what the outcome is supposed to be.

20 Of course, the patient doesn't know

21 anything until it's all over, until it's all

22 unsealed, and you have to trust the master

149 1 supervisor that no one is going unnecessarily at

2 health risk.

3 I mean, the proving that I've watched

4 have been done in Phoenix at the American Medical

5 College of Homeopathy, under Dr. Todd Rowe, who I

6 consider one of the most ethical men I've ever

7 met, and nothing bad is allowed to go on, and

8 that's how it's double blind.

9 It would be triple blind if none of them

10 knew what was going on, but the master person

11 always knows what's going on.

12 DR. LOSTRITTO: I'll keep my -- I'll

13 bullet down my question to be more brief. In your

14 state, what is the relationship between the

15 practice of homeopathy and both homeopathic

16 pharmacies and so-called conventional pharmacies

17 that would do compounding of specific homeopathic

18 remedies for you?

19 DR. SHELTON: There aren't that many

20 compounding homeopathic pharmacies in our state.

21 I mean, we rely upon the manufacturers to sell

22 these products to the doctors and the patients,

150 1 and it's my understanding that they're totally

2 looked over by the FDA in audits that could be

3 considered grueling to any business -- to have

4 someone come in and sit there and say, "What's

5 this? Why is that? Where is the data? Is it

6 clean? Is it not clean?"

7 The GMP standards that are followed by

8 these manufacturers are totally appropriate and

9 they're totally honest, and I would say further

10 about Arizona, Arizona has developed a unique

11 inter relationship between all the different

12 modalities.

13 I mean, we have a huge naturopathic

14 community that we work together -- you're going to

15 hear from the President of our homeopathic -- of

16 our naturopathic school. Even the AMA regularly

17 supports the things we do at the legislature.

18 I mean, even the AMA regularly supports

19 the things we do at the legislature. I mean, it's

20 surprising that once people start talking to each

21 other and understanding the other person's point

22 of view, what actually happens, and the prejudices

151 1 seem to dissolve. It's my goal to help dissolve

2 those barriers, not increase them.

3 DR. WHYTE: We have time for one more

4 quick question.

5 MS. LIPPMANN: You said you are in favor

6 of there being as much information as possible,

7 but you don't want there to be so much need for it

8 that it's onerous on manufacturers. Can you

9 explain what specifically about FDA's scientific

10 process for establishing safety and efficacy is

11 inconsistent with homeopathy?

12 DR. SHELTON: Personally, I think the

13 FDA is doing is job properly to some degree. I

14 mean, you're overseeing the manufacturer, which is

15 really what you're supposed to do. You're

16 overseeing the labeling, and from what I

17 understand, you're doing a good job at that.

18 You're overseeing the enforcement, and I

19 know there are some businesses and customers that

20 are unhappy, but the net result is the community

21 always benefits.

22 I think you're doing fine right now.

152 1 You don't need to do anymore. You've got enough

2 paper to deal with.

3 DR. WHYTE: Kate, did you have a quick

4 question you wanted to ask?

5 DR. BENT: You had observed that the

6 individual ingredient information is readily

7 available to the public and even more so to

8 providers, but many of the homeopathic products

9 actually have multiple ingredients.

10 So, is it sufficient that each

11 ingredient has a clinical trial, and if so, why?

12 DR. SHELTON: To be honest with you, it

13 needs to be tested as the group. I mean, I've

14 learned my homeopathy from Dr. Hans Heinrich

15 Reckeweg, who I never met, who is the father of

16 homotoxicology, which is the field where remedies

17 are mixed together to create newer remedies.

18 It's those mixtures that become a

19 different product, as opposed to the individual

20 ingredients, and taken as a single product,

21 studies on those would be great to have. I would

22 love to see someone spend the money to do that.

153 1 DR. WHYTE: Thank you.

2 DR. SHELTON: Thank you. I appreciate

3 being here.

4 DR. WHYTE: Well, thank you, Dr.

5 Shelton. And that gives me an opportunity to

6 follow up on some Washington trivia, since he said

7 there was a statue of Samuel Hahnemann.

8 You won't have time at lunch to go see

9 it because it's at 18th and Massachusetts -- 16th

10 and Massachusetts -- in Washington, D.C., but

11 perhaps you can go this evening. And there's

12 actually a statue of Daniel Webster right next to

13 it, so a great American Revolutionist.

14 I don't know if Jeannine will know him

15 from Canada, but that is our next speaker. From

16 Ottawa, Canada, Jeannine Ritchot from Health

17 Canada.

18 MS. RITCHOT: Thank you very much for

19 having me. I am -- my name is Jeannine Ritchot,

20 and I'm the Acting Director General of the Natural

21 and Non-Prescription Health Products Director at

22 Health Canada.

154 1 Full disclosure, I am about five and a

2 half weeks in to this new role, and so I do hope

3 that I will be able to answer any questions that

4 the panel has for me, and if not, I will endeavor

5 to bring back some answers for you.

6 I would like to take the opportunity --

7 oh, did I just hang up on somebody by any single

8 chance at all? I hope everybody on the webinar

9 can still hear me because I might have pressed a

10 button I shouldn't have pressed. My apologies.

11 I'm not technologically astute.

12 So, I would like to thank the FDA for

13 inviting me to come and provide an overview of how

14 homeopathic medicines are regulated in Canada.

15 Just, if you'll permit me, I think this is even

16 more important in this day and age that we work

17 together with our regulatory counterparts.

18 In an every evolving marketplace, when

19 products can cross borders much more easily than

20 they could have, I think these are important

21 conversations to have with one another and I'm

22 quite happy to be here. I'm also quite happy to

155 1 have the opportunity, as I am so new, to meet so

2 many stakeholders aside from my FDA counterparts.

3 I am going to talk a little bit about

4 how we regulate in Canada. We do have a premarket

5 regulatory framework. And I'm also going to talk

6 just a little bit about some of our current

7 context, including some of our challenges as move

8 forward in this area.

9 So, let me begin by talking a little bit

10 about Health Canada's regulatory role. Our

11 mandate, of course, is to ensure that Canadians

12 stay safe and stay healthy, and we regulate a

13 variety of commodities, whether they be consumer

14 products, whether they be drugs, whether they be

15 food.

16 In my world, the Natural and Non

17 Prescription Health Products Directorate, we

18 regulate natural health products as well as non

19 prescription drugs, and we also regulate

20 disinfectants, which are considered -- in some

21 cases are considered drugs -- and some cosmetics,

22 as well, although that's not up on the slide.

156 1 Our role is to ensure that Canadians

2 have access to these commodities -- in my world,

3 NHP's and non prescription and disinfectant drugs

4 -- that are safe, effective, and of high quality.

5 In the case of natural health products, in Canada

6 that does include homeopathic medicines.

7 So, what is a natural health product?

8 In Canada, a natural health product refers to a

9 range of products and you can see them up here on

10 the slide. Toothpaste, protein powder, minerals

11 and supplements, plant based remedies, and

12 homeopathic medicines. So the net is cast rather

13 wide with respect to natural health products.

14 In order to be authorized to see and

15 bring to market and manufacture a natural health

16 product in Canada, you do need to apply through

17 our framework, which we'll get into, and you know

18 -- consumers know that it has been authorized in

19 this premarket regulatory framework.

20 They know that it's been authorized

21 because a natural health product bears what we

22 call and NPN, or a natural product number, and a

157 1 homeopathic medicine will bear a DINHM (ph,) or a

2 drug identification number homeopathic medicine,

3 on their label. These must be displayed

4 prominently so that Canadians have confidence that

5 these have indeed been approved by Health Canada.

6 There are currently over 80,000 NHP's

7 authorized for sale in Canada. I probably should

8 have asked somebody in my office what the number

9 of homeopathic medicines were, but I didn't think

10 to do that before coming here.

11 So, let's just talk a little bit about

12 how we regulate natural health products in Canada.

13 Natural health products do have their own set of

14 regulations underneath the Food and Drugs Act. In

15 this regulatory framework, the natural health

16 products regulation came in to being in 2004.

17 These cover -- as I said, there is a

18 premarket as well as a post market regime, so we

19 cover product licensing. In order to sell and

20 manufacture a product in Canada, you must have a

21 product license, so you must come to us for

22 approval.

158 1 We also have a site licensing, so once

2 your product is approved, if you want to -- it's -

3 - for the manufacturing and the sale -- that's

4 where you also need to have your site where the

5 products are made -- licensed. And we also have

6 post market reporting requirements, as well as

7 compliance and enforcement.

8 Now, I should pause here and I should

9 just say that on the compliance and enforcement

10 side, our national compliance and enforcement

11 program is run by an organization within Health

12 Canada known as the Inspectorate, and it is

13 responsible for providing compliance and

14 enforcement, inspections, etcetera, across all

15 commodities.

16 As a result, we operate in a risk based

17 - - in a risk based way -- and it is fair to say

18 that natural health products as a category are not

19 what keeps our inspectorate the most busy, because

20 generally speaking, they are on the lower risk

21 side of all the commodities that we regulate under

22 the Food and Drugs Act.

159 1 That's not to say that it's nonexistent.

2 In fact, last week, with my colleagues from the

3 Inspectorate, we issued a recall on a homeopathic

4 product containing male fern (ph,) which was found

5 to be in excess of -- which was found to be in

6 excess of the appropriate amounts for consumption

7 - - for safe consumption. So there is a

8 compliance and enforcement arm.

9 On the premarket side, in order to

10 become licensed we require companies to submit

11 information about the safety and efficacy of the

12 product, or to meet a monographed standard. And

13 I'm going to get into a bit more detail about the

14 evidentiary standards in a moment, but for now I

15 will just say that the regulations themselves are

16 not prescriptive as they pertain to the evidence,

17 the evidence is rather outlined in guidance

18 documents. So, the evidence is policy, not -- the

19 evidence requirements are policy and not

20 regulation.

21 Homeopathic medicines do have -- do fall

22 under the definition of a natural health product,

160 1 and they are specifically referenced within the

2 regulations. They are in scope of this particular

3 regulation.

4 This was not always the case for

5 homeopathic medicines. Before the natural health

6 product regulations came into effect, homeopathic

7 medicines fell under the food and drug

8 regulations, so they were regulated as a non

9 prescription drug.

10 I should say that Health Canada -- while

11 Health Canada has always had a history of strong

12 relationships with its stakeholders -- and

13 throughout the 1990's there was a lot of

14 conversation with healthcare practitioners, with

15 industry associations, regarding whether or not

16 this regulation of homeopathic medicines as a non

17 prescription drug was appropriate, and we did hear

18 concerns from those sectors and we did work as a

19 Department with our stakeholders to try to address

20 some of those concerns.

21 One of the concerns that was raised in

22 the '90's, from particularly the homeopathic

161 1 medicines industry, was that homeopathic medicines

2 should be allowed to use condition specific

3 product claims on their labels. So, "This is a

4 homeopathic remedy effective for the treatment of

5 symptom 'x" as opposed to just the general

6 homeopathic remedy that was on the label.

7 In 1997 we did update our policy to

8 allow specific health claims as we deemed them to

9 be appropriate in a self care setting. This is,

10 again, a policy decision. It's never been

11 enshrined in the regulation itself, but it does

12 remain in effect to this date.

13 So let's just talk briefly -- and I

14 believe this is my last slide. Let's talk briefly

15 about licensing and evidence requirements for

16 medicines in Canada.

17 So, as I said, there are two ways to

18 license homeopathic medicines. There's the non

19 specific claims route, which does remain open. So

20 a label would, in that case, simply bear words to

21 the effect of, "Homeopathic remedy," or "This is a

22 homeopathic medicine." And then we have a

162 1 category for specific claims, so, "This is a

2 homeopathic remedy for the relief of 'xy'

3 symptom."

4 The licensing pathways for homeopathics,

5 there is one distinct licensing pathway for

6 homeopathics under our regulatory framework.

7 There are two others, which I'll just talk about

8 first maybe.

9 The first is the modern NHP licensing

10 pathway. So that is where evidence is stratified

11 based on the risk of that product that the

12 manufacturer wants to bring to market, and

13 depending on that risk, that will sort of lead you

14 to the type of evidence that we would require from

15 you.

16 So this can range from textbook

17 references to perhaps a positive decision from

18 another regulatory agency, or it can be clinical

19 trial data, so perhaps this is the more similar to

20 our OTC framework.

21 We also have a traditional NHP evidence

22 pathway or licensing pathway. So this is for the

163 1 use of traditional Chinese medicine, Aurvedic (ph)

2 medicine, and the evidence must point to an

3 extended history of use, and it must come from an

4 appropriate reference text.

5 With homeopathic medicines -- and this

6 is the third pathway, so again, it is a distinct

7 licensing pathway under our framework -- evidence

8 must come from an accepted homeopathic reference.

9 So we've talked a lot about them today.

10 I won't spend too much time -- I won't spend too

11 much time talking about it now. I will just say

12 that there are some products where we might get

13 evidence from a clinical trial, and that's, of

14 course, very welcome.

15 The evidence that we ask -- particularly

16 when you want to make a specific claim, we ask

17 that you provide us with evidence that supports

18 the conditions of use, claims, dose, and route of

19 administration, and again, comes from proving or

20 from homeopathic pharmacopeia or Materia Medica,

21 which have been referenced today.

22 I would just like to end by maybe

164 1 talking very briefly about the context in Canada

2 at this point today. First of all, I think it's

3 fair to acknowledge that Health Canada is a

4 science based organization, and there is a natural

5 tension that comes from a science based

6 organization working in this area.

7 That said, the Canadian government did

8 make a decision that it wanted to provide access

9 to these alternate sources of healthcare and the

10 treatments that come with them. It wanted to

11 provide access to those who have cultural or

12 philosophical, or whatever other reasons there may

13 be that they wish to have access to these as well

14 as the more traditionally pharmaceutical products.

15 So that means that we, in my role and my

16 team, are always striving to balance that natural

17 tension between the need for strong science as we

18 play our role regulators, and the need to allow

19 for access.

20 What that effectively means is that we

21 have to maintain really strong relationships with

22 our stakeholders, be they industry associations,

165 1 be they practitioners. We have regular buy lots

2 with many of our stakeholders so that we can

3 understand the issues that they are seeing, so

4 that we can understand some of the challenges in

5 this area.

6 But also as a good regulator, we have an

7 obligation to review all of our regulatory

8 frameworks on a regular basis to make sure that we

9 have it right, so I'm particularly interested in

10 my new capacity in this role, in working with my

11 international counterparts, and continuing these

12 discussions with all of the relevant players,

13 because it would be -- it would be inappropriate

14 to say that we have everything right, that we have

15 struck the exact right balance in Canada -- and we

16 continue to work with our partners and our

17 counterparts to make sure that moving forward our

18 regulatory framework in this area remains strong.

19 So, I will leave it at that. Thank you

20 very much for your time.

21 DR. WHYTE: Thank you. So we will reset

22 the clock and we have minutes of questions, and

166 1 we'll start with -- we'll start at the very -- you

2 know what? Last time we started at that end.

3 This time we'll start at this end.

4 DR. IZEM: Thank you for your

5 presentation. I have a few clarifying questions

6 for your last slide here. So the level of

7 evidence is the same for non specific claims or

8 for specific claims? And also -- yes, so that's--

9 MS. RITCHOT: In the review process, if

10 a company is making or a manufacturer is making a

11 non specific claim, then they would have to

12 provide us with evidence from -- with the specific

13 references, for example, to homeopathic

14 pharmacopeia, that state that yes, this has been

15 used to treat "xy or z" condition or symptom.

16 For specific -- for non specific claims,

17 they still have to -- they still have to point to

18 the same general references, the difference being

19 that they're not claiming that it's for something

20 specific. So the level of specificity of what

21 they point to is not quite the same.

22 DR. LOSTRITTO: Hi. Thank you. I have

167 1 three questions, but two of them are very quick.

2 The licensing for homeopathic products, is it open

3 ended or what's the duration of it before

4 relicensing, if any has to occur?

5 Second, on this line right here, you

6 have listed three types of -- three pathways for

7 licensing homeopathic products. If you could

8 briefly describe how the consumer or the physician

9 knows about these pathways.

10 And thirdly, other than the inspectorate

11 situation, when you receive information for

12 licensing, do you require any CMC information,

13 such as the quality or purity of the ingredients,

14 stability, and so forth?

15 MS. RITCHOT: Yes, thank you. And I

16 hope I -- I didn't bring a pen, so I hope I

17 remember all three questions.

18 So, the second question is what I'm

19 going to start with because I'm looking at the

20 slide here. Thank you very much. To be clear,

21 those are three pathways for all natural health

22 products, not just for homeopathic medicines.

168 1 So the first is the distinct pathway for

2 homeopathic medicines, and I should have made this

3 more clear on the slide. The second are not

4 pathways for homeopathic medicines, but for all

5 the other NHP's that come under the same

6 regulatory framework.

7 Your second question was CMC, which I

8 think might be the same as our good manufacturing

9 products. There is -- we call it GMP -- there is

10 an attestation process that is part of the

11 licensing, so manufacturers must attest to

12 upholding GMP standards.

13 On the compliance and enforcement side -

14 - in the world of mostly prescription drugs and

15 controlled substances -- for example, there's

16 mandatory inspections that doesn't exist here.

17 And I apologize because I didn't have

18 John's pen -- I do forget the first question.

19 DR. LOSTRITTO: Briefly, how long is the

20 licensing good for?

21 MS. RITCHOT: Thank you. It's open

22 ended.

169 1 MS. MICHELE: So thank you for that

2 presentation. You noted that in -- prior to 2004,

3 these products in Canada were regulated as non

4 prescription drugs, and then it changed to natural

5 health products.

6 Could you comment on how the regulatory

7 requirements changed for these products at that

8 time?

9 MS. RITCHOT: Could I comment on that

10 five and a half weeks in? I'm not sure how useful

11 it will be, but I'd be happy to get back to you

12 afterward just as a general observation.

13 I'm also responsible for over the

14 counter -- for the regulation of over the counter

15 products now, and one of the reasons that it was

16 moved into the natural health product directorate

17 is because of the acknowledgement by Health Canada

18 that, generally speaking, the gamut of self care

19 products, by no means are they all low risk

20 products, but they are more alike in terms of

21 regulation than perhaps an over the counter and a

22 prescription drug.

170 1 So they are still done rather

2 differently. There is a higher evidence standard,

3 for example, for over the counter products, but

4 they are being lumped together in one directorate

5 because of this general recognition that there's

6 more likeness between perhaps the natural health

7 product world and the over the counter, than there

8 is between prescription drug and over the counter.

9 But I would be happy to further that conversation

10 outside of this forum.

11 DR. NELSON: Thank you for your

12 presentation. I'm curious about the example you

13 gave of the enforcement action, and how that might

14 reveal thoughts about low concentration, which I

15 gather is high potency versus high concentration,

16 which is low potency, which to some might seem

17 counterintuitive, but I guess in homeopathy it's

18 not, and I appreciate that.

19 How one arrived at the potency or

20 concentration of which that product that you

21 decided was outside of the manufacturing limits

22 was in fact outside? In other words, are you

171 1 trying to make judgments of the concentration and

2 perhaps getting towards where lower concentration

3 or higher potency products would be therefore of a

4 lower risk, and how did you find out about it?

5 How do you frame that?

6 MS. RITCHOT: Absolutely. It was not

7 outside of the manufacturing limits. It was

8 outside of what we understand, based on evidence

9 about this product in particular, to be the safe

10 level of consumption.

11 In this particular case we did receive -

12 - and this is an example of, if I may brag for a

13 moment, of what I think a good regulatory agency

14 should always be doing.

15 We received an application for a

16 product, not homeopathic, that contained this

17 ingredient, male fern, and in the process of

18 looking at this we had a few other products

19 containing this ingredient already on the market

20 and approved.

21 In the process of doing the review, new

22 evidence since the last time that we have

172 1 regulated one of these products has come to light,

2 and our product application officer did what we

3 call a health risk assessment, and this caused

4 some concern with respect to levels that may be

5 existing in some of our other NHP's that we have

6 licensed.

7 So we took a look at the amounts that we

8 had previously licensed, and in this case we did

9 find in one homeopathic medicine that the dilution

10 factor was quite low. In this case I believe it

11 was possibly even the mother tincture, and as a

12 result, we removed it from the market.

13 So, it's in the process of reviewing

14 incoming product licenses, that we go back

15 sometimes and look at -- did we -- have we always

16 had it right? Or has there been new evidence that

17 comes up that makes us take a look at some of what

18 we may have already licensed?

19 MR. PACE: Are there distinctions

20 between prescription and OTC homeopathic products?

21 MS. RITCHOT: As far as I know, no,

22 there's no distinction. I'm not -- there's no

173 1 distinct category of prescription homeopathic

2 products, if that's the question.

3 DR. WHYTE: Thank you. All right. And

4 our last speaker before lunch is Melanie Grimes.

5 Melanie has some concerns about the technical

6 issues, so we'll bear with her.

7 MS. GRIMES: Thank you so much. I've

8 edited homeopathic journals for the HANP and other

9 homeopathic organizations for over 30 years. I've

10 lectured internationally and been adjunct faculty

11 at Bastyr University, and currently receive a

12 million visits a year on my websites. I've also

13 conducted homeopathic provings.

14 My father was a Naval Officer in World

15 War II, who served as a cabinet member under two

16 Presidents, as Deputy Commissioner of Education,

17 so I have a great respect for the government and

18 the Administration, and I thank you all for your

19 efforts.

20 First, I'd like to address the FDA's

21 concerns about the safety of homeopathic remedies,

22 and I want to tell you about the homeopathic

174 1 practice of Dr. Bastyr, the namesake of the

2 accredited medical university, Bastyr University.

3 Dr. Bastyr said, "I am a Homeopath," and

4 he treated 90% of his 70,000 -- 50,000 patients --

5 over five generations and seven decades with

6 homeopathy with no reported adverse events, and

7 Dr. Bastyr educated his patients in the proper use

8 of over the counter homeopathic remedies, as do

9 many of the students that he taught, and I know

10 this is something that is taught in the

11 naturopathic colleges as well.

12 Also, I want to -- secondly I want to

13 mention that I am a DES daughter. I was infertile

14 because of a damage to my uterus caused before I

15 was born by a pharmaceutical drug. I had a son

16 who died halfway through my pregnancy at 22 weeks

17 gestational age because of anatomical

18 abnormalities caused by diethylstilbestrol, an FDA

19 approved treatment against miscarriage that my

20 mother's OB prescribed, and she took dutifully

21 every day of her pregnancy. She was 24 years old

22 with no history of miscarriage.

175 1 My son, Ivan, who would be 36 years old

2 this week, weighed less than one pound at his

3 birth. He has fused fingers and eyelids, and

4 suffocated being born, and to this day no preemies

5 born at 22 gestational weeks survive.

6 After my son died, my OB told me that

7 there was a 75% chance that every pregnancy I had

8 would terminate at 22 weeks because of the DES. I

9 consulted with Dr. Bastyr, who treated me with a

10 low potency homeopathic remedy, and enabled me to

11 carry two lovely sons to term births, and I am now

12 the proud mother and grandmother, and I have Dr.

13 Bastyr and homeopathy to thank.

14 I am one of the women about whom Dr.

15 Bastyr used to boast, "I got a lot of women

16 pregnant." That's -- my father and the family

17 that we have because of homeopathy. So, this is

18 the legacy of homeopathy.

19 And I want to tell you also about Marion

20 Belle Rood. Dr. Rood was a homeopathic practice

21 at the end of a dirt road for 50 years, from noon

22 until 1:00 o'clock in the morning, until she died

176 1 at the age of 96 in 1995.

2 She testified when The Pharmacopeia was

3 reviewed in the 1980's, and she raised and

4 contributed $50,000.00 to fund the updating of the

5 U.S. Homeopathic Pharmacopeia. She charged $10.00

6 of her patients, and she raised it to $20.00, and

7 that's how she managed to do that.

8 So, over the next two days you'll hear

9 testimony from a dedicated group of homeopaths.

10 There are many more lucrative career choices than

11 homeopathy, in spite of its recent growth.

12 In my 40 years, I know of no one has

13 chosen this career for its financial gain. I know

14 of no one who has dedicated their lives to

15 dispensing placebo or sugar pills, right? I know

16 - - and I can tell you the American homeopathic

17 community is compassionate, hard working,

18 dedicated, as were their mentors like Dr. Bastyr

19 and Dr. Rood, and I know that if the FDA wants to

20 collaborate, that there are no better partners

21 than the manufacturers of the homeopathic remedies

22 and the homeopathic practitioners.

177 1 Hahnemann's motto and his credo was odes

2 operas (ph) and it means in Latin, "to dare to

3 know," and to investigate the truth it takes great

4 bravery. So I thank you all for your time.

5 DR. WHYTE: Thank you. Now we'll have

6 five minutes of questions from the panel.

7 (No audible response.)

8 DR. WHYTE: All right.

9 MS. GRIMES: Well, then can I answer

10 some of the questions that were answered before?

11 DR. WHYTE: On -- we probably have about

12 40 seconds left, so if you want use 40 seconds.

13 MS. GRIMES: Okay. First of all, I

14 would like to say that when you talk about

15 proving, also in the Materia Medica, we also use

16 clinical data. It's important to understand that.

17 Hahnemann was the inventor of the

18 sterile field. He was a scientist quite revered

19 in his day and age. President McKinley was

20 attended by a homeopathic physician, and I believe

21 if you're trying to look for the cause -- the

22 method of action of homeopathy, that the field of

178 1 epigenetics is going to start to show how

2 homeopathy works, and once we start to look at the

3 affect of these remedies on the genes, I think

4 we'll start to understand some of the ways that

5 homeopathy works.

6 DR. WHYTE: Great. Thank you. So now

7 we will break for lunch. We're running only about

8 five minutes behind schedule. If we can

9 synchronize our watches, it's 12:10, because it

10 doesn't seem like there's a clock in here. I

11 don't know. We will resume promptly at 1:10.

12 If you did not preorder your lunch, I'm

13 told you can still buy your lunch out there. So

14 see you all in one hour at 1:10.

15 (Off the record at approximately 12:10

16 p.m.)

17 (Recess.)

18 (Back on the record.)

19 DR. WHYTE: Well, good afternoon, again.

20 For those that were not here this morning, I am

21 Dr. John Whyte, the Director of the Professional

22 Affairs and Stakeholder Engagement Group here in

179 1 the Food and Drug Administration.

2 I want to thank everyone for being so

3 prompt in sticking to your time. It helps all of

4 us have an opportunity to hear from each other, as

5 well as to leave before traffic gets way too busy

6 for all of you.

7 Just a housekeeping note, there are some

8 members of the press who are here. I do want to

9 remind them that panelists should not be

10 approached directly, but instead we have our press

11 officer here, Chris Kelly, and Chris is standing.

12 So any members of the media, feel free to direct

13 your questions or inquiries to Mr. Kelly and he

14 will refer you to the right person. So that's our

15 policy here at the FDA. That's the policy that we

16 adhere to for every type of meeting.

17 So we're now going to start our

18 afternoon session and we are going to start with

19 Marcel Fraix from the Western University of Health

20 Sciences and the College of Osteopathic Medicine

21 of the Pacific.

22 DR. FRAIX: Good afternoon, everyone.

180 1 I'd like to just say thank you for being invited,

2 first of all, by the FDA, to speak on this

3 important matter. I know it's a challenge to

4 strike that balance between taking care of the

5 safety of our patients and the consumers, as well

6 as maintaining access to the things that can

7 potentially be of benefit to them.

8 So, my name is Marcel Fraix. I'm an

9 Osteopathic Physician. I actually came out here

10 from California. I am board certified in physical

11 medicine, rehabilitation, by the American Board of

12 Physical Medicine and Rehabilitation, as well as

13 the American Osteopathic Board of Physical

14 Medicine and Rehabilitation.

15 I am an Associate Professor at Western

16 University of Health Sciences, as well as the

17 Chair of that department, and I am clinically

18 active as well as -- performed research activity

19 at the University. About half of my time is spent

20 seeing patients.

21 In that regard, the patients that I

22 primarily see are in the context of pain

181 1 management, and I will be speaking a little about

2 how I integrate clinical homeopathy in the

3 practice of pain management.

4 The other part of my activities at the

5 University involve, specifically, research

6 activity, and I want to be clear on that. I am

7 not researching homeopathy, and I will not be

8 specifically focusing on the research during my

9 presentation here.

10 My focus is really to give a clinical

11 perspective as a physician, in terms of how I've

12 seen homeopathy being integrated as well as

13 address some key questions by the FDA panel.

14 Lastly, I am a teacher for the Center

15 for Education Development of Homeopathy, which

16 I've been doing for approximately a decade.

17 So, I'd like to keep this presentation

18 to the point and be fairly succinct. I will

19 definitely answer any questions that come up

20 though.

21 The first question, what are consumer

22 and healthcare provider attitudes toward human

182 1 drug and biological products labeled as

2 homeopathic? Now, again, as my perspective as a

3 clinician that integrates homeopathy into his

4 practice, I would say that amongst the patients

5 that come and see me, the vast majority are fairly

6 aware of what homeopathic medicines are. They're

7 aware of the limitations as well as the potential

8 benefits.

9 So, why is that important? Well, it's

10 important because in my clinical practice most

11 people seek me out because they know I integrate

12 this. Oftentimes they come to me because they are

13 receiving standard of care but they want more, or

14 they want an integration of standard of care and

15 using homeopathic medicines.

16 And it's important, and I really stress

17 this point, that I only treat patients with

18 clinical homeopathy when they are being provided

19 with management that is a standard of care in

20 terms of clinical practice.

21 That's a very important point, and often

22 times I see in the medical community that things

183 1 become quite polarized, that it has to be either

2 or, and that is definitely not the case.

3 You can provide symptomatic relief with

4 homeopathic medicines while at the same time

5 provide standard of care that is generally

6 accepted by the medical community.

7 So, what is a practical example and what

8 would that look like in my practice? I see a fair

9 number of patients with, for example, back pain.

10 Now, oftentimes I am having not only to diagnose

11 and treat that -- that could involve

12 interventional procedures, it can involve

13 medicines, it can be referral to one of my

14 surgical colleagues, but they also may be --

15 patients may be also interested in saying, "Well,

16 how can I potentially reduce my pain with

17 homeopathic medicines and integrate that into the

18 context of other medicines that are being used?"

19 And that's a very useful tool to me as a

20 clinician, because as -- those of us who practice

21 clinically, we know that every medicine

22 potentially has risks and it has benefits, and I

184 1 have to weigh those in the context of a specific

2 patient, and also see how the integration of

3 homeopathic medicine may avoid -- may help me

4 avoid some of the risks that I may face with more

5 conventional medicines. So, it's an integrated

6 process.

7 With regards to my colleagues and their

8 familiarity with clinical homeopathy, oftentimes I

9 find that once they are familiar with what I do

10 and we've had a conversation, especially in terms

11 of what evidence exists, the limitations and

12 benefits of homeopathic medicines, that they're

13 fairly receptive and comfortable with me since I

14 provide an integrative approach to the patients

15 that they are referring to me.

16 The second question, do consumers and

17 healthcare providers have adequate information to

18 make informed decisions about drug products

19 labeled as homeopathic?

20 Again, in the context of my clinical

21 practice, I would say that most of my patients are

22 fairly well informed of what that entails, and I

185 1 think with the advent of the internet and the wide

2 array of information that is out there, oftentimes

3 they have a lot of information that we have to

4 sift through together and to say what is useful

5 and what's not.

6 But in general, they come very well

7 prepared, and I would dare say, most of the time

8 they are more informed about homeopathic medicines

9 than they are about the conventional medicines

10 that oftentimes they are prescribed. And I think

11 that's an important point to take into

12 consideration.

13 Now, with regards to healthcare

14 providers, I'd say amongst the clinicians that I

15 help teach in the Center for Education and

16 Development of Homeopathy, they are also fairly

17 well represented in terms of understanding the

18 limitations, benefits, of homeopathic medicines,

19 and the clinical indications.

20 Now, that's, again, a bit biased because

21 I am showing -- you know, talking about a specific

22 group of individuals, but amongst those people who

186 1 make the effort and -- to understand what's going

2 on, they are fairly well versed in terms of what

3 clinical homeopathy entails.

4 So that concludes my discussion. I

5 tried to be distinct and brief and to the point,

6 but please ask me any questions.

7 DR. WHYTE: Okay. With that we'll start

8 with five minutes of questions and we'll start

9 with Kate and then we'll go from there.

10 DR. BENT: Thank you. You described to

11 us that your patients arrive well informed and

12 well prepared, and you also noted that every

13 medicine has both benefits and risks.

14 Can you tell us a little bit more about

15 what your patients understand about the risks of

16 their homeopathic treatments?

17 DR. FRAIX: I think the -- in terms of

18 risks of homeopathic medicines, I think the

19 biggest risk that they understand is that it

20 potentially may do nothing at all. That would be

21 if you want to define it as a risk. In terms of

22 there being adverse outcomes, usually they do not

187 1 have any issues regarding that.

2 DR. LOSTRITTO: Hi. What role do you

3 think labeling plays in either the problem of

4 incomplete information transfer or what role do

5 you see it playing to mitigate that?

6 DR. FRAIX: You know, I think it's hard

7 to distill a large amount of information in a

8 small label. I guess a reality that we're all

9 faced with. And I think that goes for whether

10 we're talking about a conventional medicine or a

11 homeopathic medicine.

12 I think that having some type of

13 labeling system that potentially would refer

14 patients to a more comprehensive compendium of

15 information that would allow them to educate

16 themselves more and have a discussion with their

17 healthcare provider would be helpful.

18 But I scratch my head sometimes to think

19 that -- what could we potentially do better than

20 we're doing right now?

21 DR. LOSTRITTO: Quick follow. Do you

22 see a role for med guides?

188 1 DR. FRAIX: Oh, what's that?

2 DR. LOSTRITTO: I'm sorry. Do you see a

3 role for medication guides?

4 DR. FRAIX: I'm sorry, I --

5 DR. LOSTRITTO: A role for medication

6 guides.

7 DR. FRAIX: Oh, do I see -- yes. I

8 think anything that helps the consumer or the

9 patient be more informed is an important -- would

10 be something that would be helpful.

11 DR. NELSON: I was struck by your

12 comments about patient motivation. I'm just

13 curious if you could tease that apart,

14 particularly for the new patient that arrives

15 perhaps dissatisfied, as you would say, or seeking

16 something else, and teasing apart whether they're

17 there because they just know your sort of a

18 holistic approach, or whether you're a natural --

19 you know, you do natural products of homeopathic.

20 I mean, how much do they really have an

21 understanding of each or those different

22 components, and how much of that actually emerges

189 1 after your interaction with them over time?

2 DR. FRAIX: That's a good question. I'd

3 say, by and large, most of the time we find an

4 integrated approach, which means that I will

5 provide treatment that's generally accepted by the

6 medical community and used all of the time, and

7 I'll integrate that with homeopathic medicine.

8 Having said that, there are rare

9 circumstances where I do have patients that come

10 to me and for whatever reason -- maybe they had an

11 experience in the medical community that was

12 suboptimal and they're afraid of using standard

13 care, and I have to have an extensive discussion

14 with them to understand why that arose in the

15 first place.

16 And if they're not willing to, you know,

17 provide standard of care in a circumstance that is

18 truly indicated, I inform them that I can't be

19 treating them with only homeopathic medicines.

20 Does that help? Or please clarify

21 further if you'd like more.

22 DR. NELSON: Well, it helps. I guess I

190 1 was interested in just unpacking the extent to

2 which they come into your setting with sort of

3 prior knowledge of these, at times, subtle

4 distinctions between homeopathic, naturopathic,

5 holistic, and so on and so forth, and all of the

6 various alternative complementary approaches,

7 whether that, in their mind, is clear, or is it

8 really only clear after you've had an opportunity

9 to go through it with them?

10 DR. FRAIX: Good question. Yeah. I

11 think there can be confusion that people may lump

12 homeopathic medicines into different categories,

13 let's say, like naturopathic medicine, or they may

14 have a confusion that maybe different

15 practitioners use homeopathic medicines, or who's

16 specific domain do they belong to?

17 I think at the end of the day, however,

18 we always end up -- they have a clear

19 understanding of how it potentially can be

20 integrated.

21 DR. WHYTE: Well, thank you. Our next

22 speaker is M'Lou Arnett. Hopefully I pronounced

191 1 your name correctly, from Matrixx Initiatives,

2 Incorporated.

3 MS. ARNETT: Thank you, John. Nicely

4 done on the name. It's not an easy one.

5 (Inaudible.) Is this the button?

6 DR. WHYTE: Yes.

7 MS. ARNETT: Okay. Good afternoon. My

8 name is M'Lou Arnett, and I'm the CEO of Matrixx

9 Initiatives. Thank you for the opportunity to

10 speak this afternoon. This is an important public

11 hearing regarding homeopathic product regulation.

12 By way of background, Matrixx is a

13 consumer healthcare company engaged in the

14 development and marketing of over the counter

15 homeopathic and non homeopathic products to meet

16 the healthcare needs of busy consumers suffering

17 from common, self treatable, conditions.

18 It's best products, Zicam cold remedies,

19 have been established as safe and effective in

20 reducing the duration of the common cold.

21 Customer surveys repeated over many years report

22 an extremely high degree of satisfaction with

192 1 Matrixx products, thereby confirming the public

2 interest in assuring continued ease of access to

3 these and other safe, effective, and affordable

4 homeopathic pharmaceutical products.

5 The FDA's current GPG is an appropriate

6 framework which enables companies to bring to

7 market homeopathic OTC products which are safe and

8 effective when treating minor medical conditions.

9 The CPG has served FDA and consumers well.

10 To that end, Matrixx is pleased to

11 provide its input as it concerns FDA's inquiry

12 regarding the appropriateness of the current

13 enforcement policies under the CPG, and to shed

14 light on what processes our company employs when

15 evaluating whether a drug is appropriate for

16 distribution as an OTC drug.

17 So, what makes a homeopathic product

18 appropriate for OTC use? Our company employs a

19 two-step process for establishing that a

20 homeopathic product is a appropriate for OTC use.

21 Our process is consistent with FDA's

22 compliance policy guide, 400.400, and these steps

193 1 are: One, review of the proposed formulation to

2 confirm its safety for OTC use. And, two, review

3 of proposed uses or indications.

4 First we review the proposed product

5 uses and indications. We confirm that the product

6 indications are supportive in the homeopathic

7 literature, which includes Materia Medica as well

8 as other clinical literature involving homeopathic

9 drugs.

10 We then assess whether the indications

11 for use meet the FDA/CPG requirement, which

12 stipulates that an OTC homeopathic product must be

13 intended solely for self limiting disease, a

14 condition amenable to self-diagnosis and self-

15 treatment.

16 To that end, it is Matrixx's policy to

17 require that the medical condition be one that has

18 been deemed acceptable for self-treatment under

19 FDA's OTC monograph process. As FDA knows, under

20 the OTC monograph process, FDA establishes drug

21 ingredients as generally recognized as safe and

22 effective for OTC use to treat certain medical

194 1 conditions.

2 The OTC monograph process reflects FDA's

3 determination that these medical conditions are

4 self-diagnosable, self-limiting, and self-

5 treatable, and thus appropriate for the OTC space.

6 For example, FDA has OTC drug monographs

7 for drug ingredients that can treat colds,

8 allergies, headaches, minor cuts, and indigestion.

9 Zicam Cold Remedy has indications for the common

10 cold and Zicam allergy relief has indications for

11 the relief of allergy symptoms. Both address

12 conditions acknowledged by FDA as appropriate for

13 treatment with an OTC product.

14 Second, with regard to ingredient

15 strength, the Homeophathic Pharmacopeia of the

16 United States includes a guideline that describes

17 potencies at or above which each homeopathic drug

18 ingredient may be offered for sale without a

19 prescription. That's the key step to confirm that

20 all active drug ingredients are at potencies

21 consistent with the HPUS OTC guideline for such

22 ingredients.

195 1 By following these guidelines, we ensure

2 that our homeopathic products only address

3 conditions that have been determined by FDA to be

4 self-diagnosable, self-limiting, and self-

5 treatable, and therefore appropriate for OTC use.

6 Safety remains primary. Along with

7 aligning with the HPUS, OTC guideline for potency,

8 and its review of toxicological data prior to

9 marketing homeopathic products, Matrixx post-

10 marketing, third party (inaudible) efforts

11 regularly reaffirm the safety of its products.

12 The FDA's current CPG sets forth a

13 framework that allows consumers to have safe -- to

14 have access to safe homeopathic OTC products to

15 treat minor medical conditions.

16 While Matrixx has focused its comments

17 today on its policies for determining the

18 appropriate OTC indication for use, the company's

19 commitment to safety of its products remains first

20 and foremost. The CPG has served FDA consumers

21 in the homeopathic community well. Matrixx

22 believes the current CPG is adequate to advise the

196 1 homeopathic industry on how to appropriately

2 identify products that can be marketed as OTC, and

3 that it provides FDA with an excellent guide to

4 take action where products do not comply.

5 Once again, thank you for the

6 opportunity to speak at this important meeting.

7 DR. WHYTE: And we'll start with

8 questions with -- from this side first, and we'll

9 start with -- Kate, do you have -- with Rima.

10 DR. IZEM: Thank you for the

11 presentation. You said in one of your earlier

12 slides that your products have been established as

13 safe and effective. Could you give us a little

14 bit more detail on what data was used to establish

15 the efficacy and the safety?

16 MS. ARNETT: Well, as homeopathic

17 products, we look to the HBUS for ingredients that

18 are available to us for use for the conditions we

19 intend to treat, and to the Materia Medica and

20 third party literature for information on safety

21 and efficacy. Also with certain of our products

22 we have independent clinical trials.

197 1 MS. LIPPMANN: Hi. Good afternoon. I'm

2 interested in your thoughts about the placement of

3 homeopathic products on pharmacy shelves in close

4 proximity with allopathic counterparts.

5 I'm interested to know if you think that

6 there is an implication of equivalency in that

7 placement, and I'm wondering if you or others in

8 your position make any effort to clarify or make

9 clear the distinction between homeopathic products

10 and allopathic?

11 MS. ARNETT: That's an excellent

12 question. In my experience -- most of my career

13 has been spent in OTC pharmaceuticals and personal

14 care products, and in my experience, consumers

15 really want the product that works for the

16 condition they need to treat, regardless -- you

17 know, if they're somewhat agnostic as to exactly -

18 - some of the specificity in terms of regulatory

19 framework.

20 We label all of our homeopathic products

21 on many labels of the carton, including

22 prominently on the front principle display panel,

198 1 "Homeopathic." So if a consumer is either seeking

2 a homeopathic product or seeking not to use a

3 homeopathic product, that's clear.

4 In the case of Zicam Cold Remedy, as an

5 example, it's a product that treats the common

6 cold, shortens the duration of a cold and treats

7 the symptoms.

8 A consumer coming into the store looking

9 for something because here she is suffering from a

10 cold will go to the cough/cold aisle and look at

11 the vast array of choices there, and choose from

12 among those based on what symptoms they -- you

13 know, what exactly they're suffering.

14 And so, it's completely appropriate to

15 have that along with allopathic medicines at the

16 same time because it gives the range of choices

17 and we label in order to give him or her the

18 information needed.

19 MS. LIPPMANN: And just to clarify. Do

20 you think then that there is currently sufficient

21 information in the label? You said that it's

22 marked as "homeopathic." Do you feel like that is

199 1 sufficient information for the average consumer to

2 understand what a homeopathic product is, how it

3 purports to work, and what the difference is

4 between that and a regular product?

5 MS. ARNETT: Well, what I'd like to say

6 is that I don't know that the consumer is really

7 that focused on how it purports to work or not.

8 So, I'll take the example -- what I

9 consider to be a parallel example. We go to the

10 gastrointestinal category where we have antacids,

11 H2 antagonists, and proton pump inhibitors, and

12 consumers have indigestion, and so they would go

13 and see what's available to them for OTC use and

14 make a choice based on what the label says in

15 terms of treating, and what exactly their symptoms

16 are and what their experience is, and if it works

17 for them they'll go back again.

18 I'm pretty sure most consumers, unless

19 they've had an in depth conversation with their

20 doctor, would not be able to tell us the

21 difference between an H2 antagonists and a proton

22 pump inhibitor, and what a (inaudible) cell is.

200 1 So, the -- we are very diligent about

2 making sure that if homeopathic status is

3 important, it's there. The labeling says it's a

4 self -- you know, how to use it, how long to use

5 it, how frequently to use it, active and inactive

6 are listed.

7 So, I think -- I really believe that all

8 of the information needed for a consumer with a

9 self-limiting, self-diagnosable, and self-

10 treatable condition, can pick up our product and

11 feel confident.

12 DR. LOSTRITTO: Hi. Thank you. In one

13 of your slides just a couple ago, you listed a two

14 step process and step two was, "review proposed

15 formulation to confirm safety for OTC use, and

16 that potencies meet the Homeopathic Pharmacopeia

17 of the United States.

18 Could you describe to the extent you

19 can, without disclosing proprietary information

20 perhaps, what exactly does Matrixx do to confirm

21 the quality of incoming ingredients, and to what

22 extent do you validate your processes?

201 1 I understand that you're not going to

2 take a 30c product and be able to assay that, but

3 as a check on your sicussion (ph) and dilution

4 process, do you take intermediate steps and assay

5 for content where that is analytically feasible

6 perhaps?

7 I'm just -- in general, can you comment

8 on the quality stream you have and the quality

9 controls you have for incoming ingredients to

10 final product?

11 MS. ARNETT: Sure. I'm happy to do

12 that. So all of our manufactured -- all of our

13 products are manufactured under CGNP standards and

14 compliance, and in CGNP facilities. With the

15 diluted tinctures we -- so we have a certificate

16 of analysis from our source that documents each

17 and every step of the dilution.

18 At this level, this much was found, and

19 then diluted one more, and then this -- and so on

20 and so forth, and I can't speak quite as

21 eloquently as some of our scientific colleagues

22 could on exactly what the -- but we have the C of

202 1 A (ph) for the incoming material.

2 We also have release testing for all of

3 our products. Now, our zinc products can be --

4 can and are assayed at the end for the amount of

5 zinc in them, but we have master batch records and

6 we do have release testing for all the products.

7 DR. WHYTE: We have time for one more

8 question. Dr. Michele?

9 DR. MICHELE: Thank you. So you

10 mentioned pharmacovigilance efforts. I was

11 wondering if you could elaborate a bit on what's

12 involved in those efforts and how and when you

13 might report adverse advents that you've observed

14 through those efforts to the FDA?

15 MS. ARNETT: Sure. All of our consumer

16 calls go in to SafetyCall in Minnesota, and once a

17 year we have an independent review, a complete

18 review, of absolutely every call into SafetyCall,

19 and an independent summary report written up, and

20 an evaluation investigation, a multi-step process

21 that takes -- goes down -- and they assign a

22 number of different levels, different numbers to

203 1 them in terms of the severity of the incident and

2 classifies them and categorizes them, and then dig

3 even more deeply down to determine if any of the

4 case reports really are an indication or a signal.

5 And we do that on an annual basis.

6 There are no signals, so -- but that's our third

7 party, independent pharmacovigilance efforts.

8 DR. WHYTE: Thank you.

9 MS. ARNETT: Okay.

10 DR. WHYTE: I apologize to my colleagues

11 on the right side of the room who hear a lot of

12 outbursts. That's our Office of Strategic

13 Programs retreat over there, so clearly they're

14 having a lot of good retreating, I guess.

15 So, at this point we'll turn to our next

16 speaker, Allison Teitelbaum, from the National

17 Center for Homeopathy.

18 MS. TEITELBAUMN: Good afternoon. My

19 name is Allison Teitelbaum and I am the Executive

20 Director of the National Center for Homeopathy, or

21 NCH.

22 I am a Public Health Communications

204 1 Specialist and have worked for more than a decade

2 with a variety of consumer facing organizations to

3 improve the health and lives of their

4 constituents.

5 Founded in 1974, NCH is a 501.C3, not

6 for profit organization, dedicated to promoting

7 health through homeopathy. We receive less than

8 three percent of our funding from the homeopathic

9 industry.

10 We are primarily a consumer facing

11 organization and provide general information to

12 consumers about homeopathy. We also offer some

13 more in-depth information to homeopathic

14 practitioners, however, the largest portion of our

15 mission is as a consumer facing organization, and

16 providing information to consumers.

17 Today I would like to address questions

18 one and eight as listed in the Federal Register,

19 and I'd like to start with question number one,

20 which is the question about consumer and

21 healthcare practitioner attitudes about

22 homeopathy.

205 1 As we know, the homeopathic drug

2 industry has grown tremendously over the last 25

3 years, and there is a large and growing group of

4 consumers interested in exploring ways to care for

5 their health naturally, both at home and under the

6 care of professionals.

7 This interest in natural healthcare and

8 homeopathic products has been mirrored by an

9 increased consumer demand for information about

10 homeopathy, which is reflected in the tremendous

11 growth of the NCH community.

12 For example, over the past 18 months,

13 our supporter base, which is primarily comprised

14 of consumers, has increased by 40%. During that

15 same time period, the number of visits to our

16 website has increased by 300%, and our social

17 media following has increased by 314%.

18 We also maintain an online directory of

19 resources to assist consumers in finding

20 homeopathic practitioners, and its use has risen

21 by 150% in that same time period.

22 Additionally, in 2014, we launched a

206 1 free bi-monthly webinar series for consumers

2 addressing basic homeopathic treatment for a

3 variety of self- limiting, acute care health

4 issues, such as coughs and colds, and have so far

5 welcomed more than 8,000 participants throughout

6 the series.

7 Furthermore, our interactions with

8 consumers indicate that consumer attitudes about

9 homeopathic products are very positive. We

10 receive daily testimonials from consumers about

11 how homeopathic remedies have improved their

12 health and lifestyles naturally, gently, safely,

13 and extremely cost effectively.

14 They express to us that they greatly

15 appreciate the opportunity for choice when

16 selecting over the counter remedies to use at

17 home, and when seeking treatment from a healthcare

18 professional.

19 They want the opportunity to make

20 informed decisions about healthcare that suit

21 their lifestyles and health needs, and the

22 accessibility of homeopathic remedies, over the

207 1 counter, is a major factor in this level of

2 satisfaction.

3 Now I would like to address question

4 eight about consumer and healthcare providers

5 having adequate information to make informed

6 decisions. As I've already stated, NCH serves an

7 ever growing community of consumers interested in

8 making informed decisions about their healthcare,

9 including the use of homeopathic drug products.

10 We are the homeopathic organization most

11 visible to consumers in the U.S. and we interact

12 with consumers on a daily basis. We have more

13 than 30,000 visits to our website every month, and

14 receive nearly 400 phone and email communications

15 from our constituents each week.

16 In our experience, consumers are able to

17 make informed decisions about purchasing and using

18 homeopathic products, but there is clearly a

19 demand from consumers for more information about

20 homeopathy, as evidenced by the popularity of our

21 webinar series that I mentioned before, and the

22 consumer facing information on our website.

208 1 The consumers we interact with are

2 interested in exploring the spectrum of healthcare

3 options available to them and their families.

4 They come to us for information about homeopathy

5 sometimes prior to using homeopathic remedies for

6 the first time, sometimes after having success

7 with homeopathic remedies.

8 In either case they are proactive in

9 seeking our health information and indicate that

10 we are providing them with the information they

11 are looking for.

12 I appreciate the opportunity to

13 participate in this hearing and I thank you for

14 your attention.

15 DR. WHYTE: Thank you. So we have five

16 minutes of questions.

17 DR. LOSTRITTO: Thank you. I appreciate

18 your comment regarding choice, and I'd like to

19 know what your opinion or feeling -- or your

20 organization's feeling on whether further

21 delineation via labeling and other things between

22 - - placement on product shelves and so forth --

209 1 between homeopathic products and other products --

2 would that aid choice or hinder choice or hinder

3 choice selection -- proper choice selection, in

4 your opinion?

5 MS. TEITELBAUM: So, to make sure I

6 understand the question correctly, would there

7 need to be further distinction on labeling or

8 packaging so that people know that they're

9 purchasing a homeopathic product versus something

10 else?

11 DR. LOSTRITTO: Correct.

12 MS. TEITELBAUM: Okay. Well, I think to

13 echo the sentiment of the previous speaker, when

14 we talk to consumers and the people who are coming

15 to us for information, what they want is relief

16 from their symptoms, and they definitely want to

17 know -- you know, if they've seen that there's a

18 product labeled as homeopathic, or they've heard

19 of something that's homeopathic that can be

20 effective, that some of them want more

21 information.

22 But in terms of going into a store and

210 1 making a decision about what product to choose,

2 what they're really looking for is something

3 that's going to relieve their symptoms, and so, to

4 them, at the time of making that decision, some

5 may be well informed about what product it is

6 they're choosing as homeopathic, but in the end,

7 what they want is relief and once they see that

8 relief, whether it be from a traditional

9 medication or from a homeopathic product, then

10 they may go back and purchase it again.

11 At that point, they may come to us for

12 additional information, saying, "Hey, this product

13 worked for me. I want to learn more about what

14 this is."

15 But, you know, in terms of them feeling

16 like they're able to make that decision, I don't

17 think that there needs to be further delineation

18 on packaging.

19 DR. WHYTE: Okay. Well, thank you. Our

20 next speaker is Janine Jagger from the Familial

21 Mediterranean Fever Foundation.

22 MS. JAGGER: Thank you. I really

211 1 appreciate this opportunity to provide some input

2 on the medications provided by the homeopathic

3 practitioners.

4 I'm Janine Jagger, and I have no

5 conflict of interest, either financial or

6 otherwise. I am President of the Familial

7 Mediterranean Fever Foundation. I am also a

8 Professor of Medicine at the University of

9 Virginia.

10 The FMF Foundation represents patients

11 with a genetic inflammatory disease that, if

12 untreated, involves extreme pain in various forms.

13 FMF is life threatening for certain patients who

14 develop amyloidosis. Amyloidosis can be fatal,

15 but is preventable with treatment.

16 The discovery of colchicine -- Latin

17 term, colchicum autumnale -- as an effective anti-

18 inflammatory treatment for FMF, was introduced in

19 1972 and has saved thousands of lives of FMF

20 patients worldwide, and has dramatically eased the

21 suffering from extreme forms of pain.

22 Colchicine remains the gold standard of

212 1 treatment for FMF worldwide, and is so specific to

2 FMF pathology that a positive response to it is

3 still the single criteria that confirms diagnosis

4 of FMF.

5 Let me state clearly that the efficacy

6 of colchicine has been unequivocally established

7 in a multitude of trials and scientific studies.

8 The dosage and drug interactions and safety

9 perimeters have been well established in the peer

10 review medical literature.

11 Unfortunately, over the counter

12 homeopathic products sold in the U.S. pose a

13 serious threat to patients with FMF. Over the

14 counter homeopathic products labeled, "colchicum

15 autumnale" in pill form are sold in the U.S. and

16 health food stores, and online.

17 There are multiple products available

18 with various homeopathic dilutions of colchicum

19 autumnale indicated as active ingredients on the

20 label. The various dilutions found in these

21 products include, in their terms, 6c, 9c, 12c,

22 15c, 30c, 200ck, 1 in 10, and 4x, 6x, 16x, 30x.

213 1 All of these dilutions, according to homeopathic

2 theory, are purported to have different

3 therapeutic effects.

4 FMF patients see these products in

5 health food stores and believe that because the

6 label says, "colchicum autumnale," that these

7 products are an over the counter form of

8 colchicine, when in fact there is no therapeutic

9 colchicine in these products.

10 Clearly, the individuals who purchase

11 homeopathic colchicine do not know that, number

12 one, they are foregoing actual colchicine

13 treatment by taking homeopathic preparation of

14 colchicum autumnale. And two, homeopathic theory

15 is based on "like treats like," such that

16 conforming to the tenants of homeopathy, an anti-

17 inflammatory substance is the opposite of the

18 substance that would treat an inflammatory

19 condition.

20 Clearly, products are not being

21 purchased because patients understand and are

22 conforming to the theory of homeopathy. They see

214 1 a product with a name on the label and they assume

2 they are buying that product.

3 FMF patients must be informed with an

4 explicit label warning of the danger of

5 substituting homeopathic colchicum autumnale for

6 FDA regulated colchicine.

7 There's a complacency about the

8 consequences when consumers take nothing in place

9 of a drug that has been proven effective, because

10 it's believed that nothing has no side effects and

11 no toxic dose, but I wish to make clear, in the

12 case of FMF, a genetic inflammatory disease, that

13 substituting nothing for prescription colchicine

14 is a very serious -- is very serious for the

15 patient who is deprived of a well documented,

16 effective, and life saving therapy.

17 When an FMF patient chooses homeopathic

18 colchicum autumnale over colchicine, they replace

19 an effective treatment with a deceptive illusion

20 of treatment.

21 The purveyors of homeopathic products

22 depend on the ignorance of consumers to maximize

215 1 sales. When consumers do not understand the

2 homeopathic theory of "like treats like," they

3 simply select products by the name on the label.

4 I would ask that the FDA provide very

5 explicit labels to avoid this kind of mistake by

6 consumers. Thank you.

7 DR. WHYTE: Dr. Michele?

8 DR. MICHELE: Thank you so much for that

9 presentation. I'm just wondering if you are aware

10 of any adverse events in terms of disease

11 (inaudible,) of patients with Familial

12 Mediterranean Fever, who have taken the

13 homeopathic product in lieu of prescription

14 colchicine, and if so, if any of those have been

15 reported to the FDA on our MedWatch (ph) program?

16 MS. JAGGER: Um, the incidents that have

17 brought this to my attention have been cases where

18 patients have discussed purchasing this

19 homeopathic colchicum autumnale. In those cases,

20 I have very quickly told them that they are not

21 taking colchicine, so fortunately there's been no

22 long term -- that I know of -- no long term effect

216 1 among patients -- discussing this matter in

2 patient forums.

3 However, whether this has occurred among

4 patients who do not bring this to the patient

5 community, I do not know. It's a question of

6 avoiding a serious potential consequence that

7 concerns me.

8 MR. PACE: You indicated that there was

9 some consumer confusion. Do you have any specific

10 recommendations for FDA to ensure that people have

11 adequate information to make an informed decision?

12 MS. JAGGER: Well, certainly in the case

13 of colchicum autumnale, there should be a warning

14 that this is not a product that should be taken

15 for the treatment of Familial Mediterranean Fever.

16 And I think that, you know, in cases

17 where there is a, you know, physician, as the

18 person here described before -- prescribing his

19 homeopathic medication in which they actually know

20 what the real treatment is -- and they prescribe

21 the appropriate treatment.

22 Under those conditions, this situation

217 1 can be avoided. It's over the counter, where you

2 just pick what you see off the shelf, that leads

3 to this circumstance. I think there needs to be

4 true medical professional discrimination among

5 homeopathic products, and clinically demonstrated

6 and accepted treatments.

7 DR. LOSTRITTO: Hi. Thank you for

8 pointing out this very important problem. Maybe

9 you mentioned it and perhaps I missed it -- can

10 you give some indication of the scope of this

11 problem and the depth of it in terms of number of

12 patients and what outcomes occurred?

13 MS. JAGGER: Well, Familial

14 Mediterranean Fever is a rare disease, so there

15 are few cases of this disease at all -- so the

16 numbers are not large for a rare disease.

17 However, what I wish to say is to

18 provide an example of that, giving nothing in

19 place of an actual treatment is not necessarily

20 harmless, and I wish to demonstrate that with the

21 situation of Familial Mediterranean Fever.

22 But also, I have a responsibility to

218 1 provide beneficial advice to the patients who have

2 FMF, and I would like to have help from the FDA.

3 I have to explain this over and over and over to

4 patients. "Don't take colchicum autumnale in

5 homeopathic preparation in place of colchicine."

6 And there are cases that I'll never have

7 the chance to explain that to, and unless there is

8 regulation or an explicit label on the product,

9 patients have no way of knowing.

10 DR. LOSTRITTO: Thank you.

11 DR. WHYTE: Next we have a trio of

12 panelists. I'm not sure how this is going to

13 work. I guess you will all be speaking

14 sequentially, or will you be speaking --

15 MR. LAND: Yes, sequentially.

16 DR. WHYTE: -- concurrently? I don't

17 know. So, we have Mark Land, Mark Phillips, and

18 Eric Foxman, from the American Assosication of

19 Homeopathic Pharmacists.

20 MR. LAND: Thank you. Good afternoon.

21 My name is Mark Land and I am presenting today in

22 my capacity as President of the American

219 1 Association of Homeopathic Pharmacists.

2 I'm also a member of the Homeopathic

3 Pharmacopeia Commission of the United States. I

4 am Vice President of Operations and Regulatory

5 Affairs, (inaudible,) a manufacturer of

6 homeopathic drugs, and I've been in this industry

7 for 35 years with a focus on regulatory policy for

8 non prescription drugs.

9 I'd like to thank FDA for organizing

10 this hearing and for the opportunity to provide

11 information regarding the regulatory framework for

12 homeopathic drugs in the United States. I am

13 joined today by Eric Foxman and Mark Phillips,

14 also of the AAHP.

15 The AAHP is a leading trade association

16 for the homeopathic industry as has represented

17 U.S. manufacturers of homeopathic drugs since

18 1923. Our 29 members manufacture 90% of the

19 homeopathic drug products sold in the United

20 States.

21 The first operating principle of the

22 AAHP's mission statement is to encourage

220 1 regulatory compliance among our members. Our

2 dedication to regulatory compliance underscores

3 AAHP's commitment to partner with FDA in its

4 healthcare mission.

5 As part of our regulatory compliance

6 mission, AAHP sponsors an education program

7 entitled Compliance Through Education, delivered

8 via webinars, seminars, white papers, and

9 technical articles. The goals of this program is

10 to inform audiences about compliance, regulatory

11 developments, and scientific information related

12 to homeopathic drugs.

13 These educational efforts reach members

14 and non members alike and amplify FDA's messages

15 regarding regulatory compliance.

16 The current compliance policy guide

17 conditions under which homeopathic drugs may be

18 marketed was developed collaboratively with FDA

19 officials. Discussions between FDA and industry

20 yielded a regulatory framework with a record of

21 effectiveness and efficiency guiding the work of

22 the industry and providing FDA with broad

221 1 enforcement authority to protect and promote

2 public health.

3 For many years following the

4 implementation of the CPG, FDA had a point person

5 for issues regarding homeopathic drugs. This led

6 to proactive, two-way dialogue. FDA was an

7 information source for the AAHP, and AAHP made FDA

8 aware of potentially misbranded products.

9 At this time, AAHP recommends that FDA

10 and industry dedicate resources to work to

11 facilitate ongoing communications on homeopathic

12 issues. Safety is a hallmark of homeopathic

13 drugs. I would like to reinforce a few points --

14 important points made earlier in other

15 presentations today.

16 First, the term "exposure" is not

17 synonymous with adverse event. We also learned

18 from Dr. Krenzelok that total exposures to

19 homeopathic drugs in a given year are less than

20 one percent of all reports for pharmaceutical

21 products to poison centers. The rate of exposures

22 is generally below the rate of market share for

222 1 homeopathic drugs in the United States. We are

2 not aware of any evidence suggesting safety

3 concerns for homeopathic drugs at this time.

4 In addition, like all pharmaceutical

5 drug products, labelers of homeopathic drugs are

6 required to report serious adverse events to FDA's

7 MedWatch program, and do so. FDA routinely

8 inspects our pharmicovigilence systems as well.

9 The size of the homeopathic industry in

10 the United States is subject to debate. FDA

11 reported three billion dollars annually in the

12 Federal Register announcement for this hearing,

13 however, AAHP estimates the market size to be

14 between eight hundred million and one billion

15 dollars based on commercial sales information

16 sources.

17 What is not in debate is the industry is

18 growing at a rate that closely follows the growth

19 of non prescription drugs in general. Similarly,

20 new product introductions are projected at less

21 than five percent per year.

22 At this time, I would like to answer

223 1 some questions -- the questions specifically asked

2 by FDA in the Federal Register announcements for

3 this hearing.

4 Question one, what are consumer and

5 healthcare provider attitudes towards homeopathic

6 drugs? Consumers most likely to buy homeopathic

7 drugs are committed to their health and devote

8 considerable research effort in evaluating their

9 healthcare choices. Many consumers buy

10 homeopathic drugs based on the advice of

11 healthcare providers, friends, family members, and

12 internet research.

13 An online survey, a consumer survey,

14 shows advice from family and health related

15 websites were the primary sources of information

16 about homeopathic drugs, followed by doctors,

17 friends, magazines, and pharmacists.

18 Turning to healthcare professionals,

19 attitudes -- attitudes -- today, as many as 20,000

20 physicians incorporate homeopathic drugs into

21 their daily practice. Physicians rely on

22 manufacturers to produce high quality drugs when

224 1 treating their patients, and physicians welcome

2 label information, such as warnings, to inform

3 consumers of signs of disease progression.

4 Question two, what data sources can be

5 identified and shared with FDA regarding risk

6 benefits of homeopathic drugs?

7 In addition to the Poison Center data

8 that we've talked about, the AAHP recommends that

9 the FDA look to websites, regulatory authorities

10 in ICH regions, as well as a number of homeopathic

11 organizations, for information regarding risks and

12 benefits for homeopathic drugs. These include the

13 AAHP's website, the Homeopathic Pharmacopeia

14 Commission of the United States, and the American

15 Institute for Homeopathy.

16 Moving to question three, are current

17 enforcement policies under the CPG appropriate to

18 protect public health?

19 The current compliance policy guide has

20 a successful 25 year record of providing FDA with

21 broad enforcement authority in industry with

22 appropriate guidance. Importantly, the CPG

225 1 supports FDA's actions against misbranded

2 products.

3 Over the last ten years FDA has issued

4 43 general, non GNP, warning letters, often citing

5 misbranding due to non-OTC indications in

6 combinations of homeopathic and non homeopathic

7 ingredients. In all these misbranding letters,

8 FDA found adequate support within the CPG to

9 advance its arguments.

10 The FDA has taken swift and

11 comprehensive action when necessary to address

12 problem products in the marketplace with the

13 support of the CPG.

14 Homeopathic drugs are manufactured in

15 facilities registered with FDA and routinely

16 inspected by FDA. The current compliance policy

17 guide is working and is effective. AAHP

18 recommends that FDA maintain existing surveillance

19 and enforcement activities.

20 Question four, are there areas of the

21 current CPG that could benefit from additional

22 clarity?

226 1 Although the current compliance policy

2 guide speaks at length regarding the indications

3 for use in prescription versus OTC status,

4 industry lacks clarity regarding the range of

5 symptoms, indications for use, and therapeutic

6 categories amenable to self diagnosis and

7 treatment. AAHP recommends that FDA engage

8 homeopathic medical experts in this area.

9 Question five, is there information

10 regarding the regulation of homeopathic products

11 in other countries that could inform FDA's

12 thinking in this area?

13 Homeopathic drugs are regulated as drugs

14 in most countries. In regions where premarket

15 authorization is required, regulatory authorities

16 require market authorization application dossiers

17 adapted to the unique nature of homeopathic drugs.

18 In European Union, application dossiers

19 are based on the CTD format. In general, market

20 authorization is granted based on the quality and

21 safety information, and efficacy information found

22 in the homeopathic literature.

227 1 Premarket authorization processes are

2 resource intensive for regulatory authorities, and

3 backlogs of more than three years are common in

4 Europe. Individual premarket approval regimes are

5 burdensome, long, and costly, to both FDA and

6 industry.

7 What would be the appropriate regulatory

8 process for evaluating such indications for use?

9 The vast majority of homeopathic drugs, or drug

10 products, are appropriately labeled in compliance

11 with HPIS guidelines and FDA regulations.

12 Branded products at retail generally

13 fall into therapeutic categories established by

14 FDA through the OTC review, as amenable to self

15 diagnosis and treatment by lay persons.

16 AAHP supports FDA regarding responsible

17 labeling of OTC products, and we have acted

18 against mislabeled products and in support of FDA

19 action against OTC homeopathic products labeled

20 for the treatment of serious medical conditions,

21 including asthma and diabetes.

22 The AAHP supports enforcement action by

228 1 FDA directed against these types of products. At

2 AAHP, we believe the Agency's current regulatory

3 approach embodied in the CPG is in fact the

4 appropriate approach for this regulatory process.

5 Throughout the world, the homeopathic

6 literature is generally the standard used by

7 regulatory bodies when evaluating homeopathic

8 drugs. We believe the current approach is the

9 shortest access to safe, high quality, and cost

10 effective drugs to consumers who want the choice

11 for homeopathic drugs.

12 At this time, I would like to turn the

13 presentation over to Eric Foxman, Secretary of the

14 AAHP, to provide more information regarding

15 question seven.

16 MR. FOXMAN: Thank you, Mark. I'm Eric

17 Foxman. I'm a licensed Pharmacist, and have been

18 for over 35 years. I'm on the Board of the

19 American Association of Homeopathic Pharmacists,

20 and have been so for over half of that time.

21 I'm also a member of the HPCUS, and I

22 provide consulting services to people who are

229 1 interested in homeopathic drug products.

2 Thank you for giving me this opportunity

3 to address one of the specific issues raised by

4 the Agency. I will address FDA's question posed

5 in its Federal Register notice. What processes do

6 companies currently use to evaluate whether their

7 products, including indications, are appropriate

8 for marketing as an OTC drug?

9 To respond to this question, the AAHP

10 surveyed its membership. The survey shows that

11 the AAHP member firms follow a deliberate approach

12 when developing OTC indications. The majority

13 looked to FDA's tentative and final monographs

14 when establishing indications for use.

15 Let's take a look at this survey. It

16 was fielded just a few weeks ago in preparation

17 for this particular hearing. Twenty eight

18 companies, 97% of the voting membership of the

19 AAHP, responded to the survey. As Mr. Land has

20 already previously noted, we estimate this to be

21 approximately 90% of the OTC homeopathic market.

22 The first questions were simple "yes"

230 1 and "no" questions to gauge the applicability of

2 the more detailed following questions. Of the

3 respondents, all but two companies market and

4 label products as OTC homeopathic drug products.

5 Those particular two exceptions market no

6 homeopathic products under their own label, they

7 only manufacture for other companies.

8 All of the respondents indicate that the

9 OTC products they manufacture or market meet the

10 guidelines for safe OTC attenuation levels found

11 in the HPUS. Approximately two thirds of the

12 respondents use the wording in the FDA's OTC

13 final, or tentative final monographs, as a guide

14 when evaluating label indications for their OTC

15 homeopathic drug products.

16 Several companies indicated that the

17 wording in the monographs is sometimes slightly

18 modified or simplified, without changing the

19 meaning, in order to meet label space constraints.

20 The balance of our survey consisted of

21 open ended questions to ascertain the methods or

22 processes used to determine that products are

231 1 appropriate for OTC sale.

2 Respondents reported using an average of

3 four different methods to make their evaluations.

4 These methods include the use of indications,

5 which meet the definition in the Agency's

6 compliance policy guide for products that may be

7 marketed OTC. In other words, quote, "self-

8 limiting disease conditions amenable to self-

9 diagnosis;" comparison with non homeopathic or

10 allopathic OTC products that are presently

11 available in the U.S. market; review of warning

12 letters issued by the Agency to the wider

13 pharmaceutical and dietary supplement industry;

14 close adherence to indications listed in the

15 homeopathic literature when evaluating their OTC

16 label wording; and adherence to HPUS guidelines.

17 I need to take a little moment and point

18 out that this 21% adherence to HPUS guidelines

19 needs to be viewed in conjunction with the prior

20 question that revealed 100% compliance with HPUS

21 safe OTC attenuation levels.

22 These particular responses refer to the

232 1 HPUS labeling guidelines, which in terms of OTC or

2 RX labeling, simply cross reference to existing

3 21CFR regulations. A redraft of that document has

4 recently completed its public comment period, but

5 it provides no additional information or

6 distinction regarding OTC indications. It merely

7 provides more detailed information.

8 Members take a number of additional

9 steps when considering the marketing of OTC

10 products. These include review of published

11 clinical, scientific, experience, and trials

12 information, consumer insight, and market research

13 surveys, toxicity studies or reviews, including

14 adverse event reporting, marketing authorization

15 for similar products in other countries, internal

16 formal corporate review and claim study, and legal

17 review.

18 The results clearly show that our

19 respondents are aware of the boundary between OTC

20 and prescription only indications. They make use

21 of both internal and independent outside

22 information sources when evaluating label

233 1 indications, and they adhere to the guidelines

2 published in the HPUS and are guided by the OTC

3 monograph process.

4 The vast majority of homeopathic OTC

5 drug products are appropriately labeled in

6 compliance with both FDA regulations as published

7 in the CFR, and with the HPUS.

8 The AAHP wants to emphasize that

9 homeopathic drug products, those which are

10 intended for indications clearly requiring medical

11 intervention, but which are mislabeled as OTC

12 homeopathic drug products -- these products are

13 outlier products. The AAHP supports enforcement

14 action by the Agency, under the CPG, directed

15 against these outlier products.

16 I now turn the podium to Dr. Phillips

17 who will provide information on the final question

18 posed by the Agency.

19 DR. PHILLIPS: Thank you, Eric. My name

20 is Mark Phillips. I have been a licensed

21 Pharmacist for 35 years, focusing on the

22 manufacture of homeopathic drugs and consumer

234 1 education on the use of homeopathic drugs.

2 I am presenting today in my capacity as

3 a Board Director of the American Association of

4 Homeopathic Pharmacists. I am a member of HPCUS,

5 and Vice Chairman of Standard Homeopathic Company

6 and Hyland's, a manufacturer of homeopathic drugs

7 in the United States since 1903.

8 FDA's final question centered on

9 information needed to make informed decisions

10 about homeopathic products. The current

11 compliance policy guide provides significant

12 guidance for labelers of homeopathic drugs, as

13 product labeling is pivotal to adequately inform

14 consumers.

15 Homeopathic drug products found at

16 retail are labeled with four cardinal categories

17 of information, including ingredients, uses,

18 directions for use, and warnings. Label

19 information is clearly presented in drug facts

20 format. The AAHP and HPUS labeling guidelines

21 require that products bear the words "

22 {homeopathic" or "homeopathic medicines."

235 1 In August of 2012, to better inform

2 consumers about the homeopathic nature of these

3 products, the AAHP adopted revisions to its

4 longstanding advertising guideline. The revisions

5 require consumer advertising for an OTC

6 homeopathic drug to include, "These statements

7 have not been reviewed by the Food and Drug

8 Administration." The Association also urges

9 members to use the same wording on labels and

10 labeling. This was based on the disclaimer

11 enacted by Congress as part of the Dietary

12 Supplement Health and Education Act.

13 The advertising and labeling disclaimer

14 has been widely adopted by AAHP members and

15 appears on increasing number of ads and on labels

16 as existing packages sell through.

17 In addition to this important

18 information, I find that manufacturers are

19 increasing consumer access to pharmacists, nurses,

20 and other healthcare professionals trained in

21 homeopathic pharmacy to respond to their questions

22 through various mediums such as toll free consumer

236 1 hotlines.

2 Poison Control Centers are also

3 increasing the breadth and depth of their

4 resources to provide information to consumers and

5 healthcare professionals, such as with the

6 expansion of homeopathic drug listings in the

7 poison deck system database.

8 Labeling is adequate to properly inform

9 consumers as they compare homeopathic as well as

10 allopathic OTC drug options to self-diagnose and

11 self-treat their self-limiting conditions,

12 including warnings when to discontinue use and

13 contract their healthcare practitioner.

14 Manufacturers serve their consumers by

15 making available an abundance of homeopathic drug

16 information. Consumers are able to understand

17 and make informed decisions about their healthcare

18 choices from this information.

19 Mr. Land will conclude for AAHP. Mr.

20 Land?

21 MR. LAND: Thank you, Mark. In

22 conclusion, I would like to reinforce a few

237 1 points.

2 First, the Compliance Policy Guide

3 enjoys a record of success and continues to be a

4 workable platform for the regulation of

5 homeopathic drugs in the United States.

6 Homeopathic drugs are of high quality and labeled

7 clearly for consumer and healthcare provider use.

8 And finally, I would like to reiterate

9 AAHP's commitment, as the leading trade

10 association for the homeopathic drug industry, to

11 partner with FDA in its goal for protecting public

12 health. Thank you, and I would be glad to answer

13 any questions.

14 DR. WHYTE: Well, thank you, gentlemen.

15 I'm not sure how -- I'll let you guys decide how -

16 - who will answer what question -- and we'll start

17 the questions. Let's start again -- well, all

18 right, since you had your hand up, let's start

19 with Skip. Maybe we'll start with Skip and then

20 we'll move to Kate, and then we'll go down that

21 way.

22 MR. WU: Okay. Thank you very much for

238 1 the nice presentation. I have a question

2 regarding the -- how the manufacturer ensures the

3 high quality of the product? This is also because

4 we are in the botanical team.

5 So, for some of the products, probably

6 the raw material comes from different plants or

7 botanicals. How do you control, you know, the

8 quality of these material used?

9 MR. PHILLIPS: Thank you for your

10 question. Homeopathic manufacturers manufacture

11 in accordance with CFR's and GMP's, just like any

12 other drug manufacturer.

13 We're manufacturing from ingredients in

14 the USP, as well as in the Homeopathic

15 Pharmacopeia of the United States. Within the

16 Homeopathic Pharmacopeia, there are experts that

17 look at starting materials as well as tinctures,

18 and identify identification tests, and where

19 necessary, assays to evaluate both quality and the

20 safety of the medicines.

21 MR. WU: Thank you.

22 DR. BENT: I have a similar type of

239 1 question perhaps for Mr. Land and Mr. Foxman.

2 You both noted that your members produce

3 90% of the products. What percent of producers

4 are members, and are there differences in how

5 member and non members enforce, or ensure that

6 there's consistent safety and quality of their

7 materials, and are there difference in the

8 information available to you and your organization

9 about those practices?

10 MR. LAND: We represent 90% of the

11 products made or sold at retail in the United

12 States. That's our estimate based on what we

13 know, and based -- even with a certain uncertainty

14 factor that we added into the potentials that we

15 don't know about.

16 And we represent 29 manufacturing firms.

17 We have 35 members in total. We anticipate that

18 there are somewhere between 50 and 80 marketers of

19 homeopathic medicines in the United States, so

20 while we are 90% of the volume, we're slightly

21 less than 50% in terms of number, but those

22 remaining 50% represent 10% of the products sold

240 1 in the United States.

2 We are reasonably sure that our members

3 commit to the policies of the AAHP. They

4 certainly benefit from our educational efforts.

5 Not only the efforts that I mentioned in terms of

6 educational outreach, but they also have an

7 opportunity to phone in and ask questions specific

8 -- that are of specific nature to their firm --

9 which we respond to with our scientific team.

10 With respect to other firms, I can't

11 speak to firms that are not part of the AAHP. I

12 can't speak to -- in exact terms -- to what the

13 quality of their products are, however, I, as a

14 person who surveys my local CVS from time to time

15 and observes what homeopathic products are there -

16 - I'm not often troubled by what I see there in

17 terms of mislabeled products or products of

18 suspect quality.

19 MR. NELSON: Thanks. Throughout your

20 presentation you mentioned reliance on the OTC

21 monograph for indication and the like, and I'd

22 like to just explore, or give you an opportunity

241 1 to explore a bit, the depth of your reliance on

2 the OTC monograph.

3 If FDA did decide through rulemaking,

4 which would have to be the process, to make

5 revisions in one or more monographs that impacted

6 on the homeopathic products, would you also say

7 that those homeopathic products ought to be held

8 to those same changes and those same standards?

9 MR. LAND: Uh, the same changes --

10 standards -- as if to say the -- if FDA was to

11 make modifications to an OTC monograph, in terms

12 of warnings or indications for use, or one of

13 those perimeters, we -- I'll speak personally, but

14 I think I speak for Mark and Eric as well -- I

15 personally look at the OTC review and the data

16 that's found there, to be information that has

17 been developed over many years of experience on

18 the part of industry and FDA, and it is an

19 extremely valuable source of information for

20 labelers of over the counter medicines in general.

21 And to the extent that those monographs

22 would be changed, I think that that would be a

242 1 very important piece of information for labelers

2 of homeopathic medicines as well.

3 MR. PACE: You stated in your

4 presentation that the definition of a homeopathic

5 drug needs clarification. So, one, why do you

6 think that? And two, how could it better be

7 defined?

8 MR. LAND: I specifically -- in the

9 slide, what I was referring to was the combination

10 of homeopathic active ingredients and in

11 combination with other ingredients or active

12 ingredients, and I think some of our presenters

13 earlier today spoke to the same thing.

14 And, there is a -- there are

15 opportunities to make combinations of products,

16 including homeopathic active ingredients, that I

17 think were not anticipated by the CPG when it was

18 developed, and it probably would be best I the

19 definition was amended to refer to those

20 particular conditions or address them in writing

21 so that it would be clear for labelers of our

22 products.

243 1 MS. LIPPMANN: On that same slide you

2 suggest that there's a lack of clarity on the

3 range of symptoms, indications, and therapeutic

4 categories amenable to self-diagnosis and self-

5 treatment.

6 Are you saying that you would like FDA

7 to weigh in more on appropriate uses of

8 homeopathic products, and if so, how would you

9 foresee us doing that short of determining safety

10 and efficacy through an approval process?

11 MR. LAND: Uh, I think that we have

12 1,295 individual active ingredients included in

13 the Homeopathic Pharmacopeia of the United States,

14 and those ingredients can be used for a wide

15 variety of indications, as you can imagine.

16 The OTC Drug Review today, when we

17 include the original monographs, the tentative and

18 final monographs, as well as those substances or

19 those categories that have been created by OTC

20 switch, is about 80 categories.

21 There are probably -- within the

22 (inaudible) of Homeopathic Drugs, there are

244 1 categories that could be addressed on a self

2 medication basis that are outside of those 80

3 categories.

4 MS. LIPPMANN: And one more quick

5 question. On an earlier slide you say that

6 consumers that are most likely to buy homeopathic

7 medicines do considerable research. Do you have

8 data to support that? And also what do you

9 consider to be considerable research?

10 MR. LAND: The data that I'm referring

11 to was a study that was actually performed by my

12 company several years ago, which was seeking to

13 identify the habits of consumers who are

14 interested in buying homeopathic medicines, and we

15 found in our research that those folks that are

16 most likely to buy these products tend to be very

17 active in their health.

18 They tend to be constantly looking for

19 new ways to promote their own health, and

20 therefore by nature, they're researching all the

21 time.

22 If I think about my wife, she goes to

245 1 the store and she buys something off the shelf

2 that she was -- either her mother bought, or that

3 she discovered when she was in the store. That

4 would be -- I would term "0" research versus

5 someone who goes to a WebMD website and maybe

6 looks for opportunity -- or looks for information

7 regarding a particular medical product or a

8 particular medical condition. Maybe that's a

9 medium range.

10 And someone who actively engages in

11 alternative approaches, or multiple approaches to

12 treating a condition, that would probably be a

13 consumer that's more likely to use a homeopathic

14 medicine.

15 DR. LOSTRITTO: Thank you. I want to

16 shift gears a little bit and focus on new product

17 development that you touched on, and specifically,

18 is the CPG enough? So I've been waiting for some

19 pharmacists to come up here, and this may be the

20 only group of pharmacists we actually see today.

21 In terms of new product development, you

22 know it's possible to completely follow GNP, end

246 1 up with a failed product, if development preceding

2 that hasn't been done scientifically and

3 effectively.

4 Specifically, when developing a new

5 product, what sorts of protocols do you take into

6 account to make sure that the dilutions are going

7 to be accurate, because some of these materials

8 can be surface active, they can absorb the glass,

9 they are normally manufacturing losses, and these

10 can be substantial in either under or overloading

11 a specific dilution with an amount of material,

12 and I'm just curious if you can summarize briefly

13 what do during development to ensure that you have

14 that quality aspect controlled?

15 MR. LAND: Well, I think that -- I'll

16 speak from maybe the experience of my own company.

17 We -- first of all, generally manufacture products

18 in dosage forms that we are familiar with, so

19 we're not going to novel an exotic dosage form,

20 and that serves the purpose of simplicity and

21 economics as well.

22 So, we're working with dosage forms and

247 1 formulations that we're familiar with. We

2 formulate based on general principles of

3 formulation for drug products in general, and we

4 test and we validate based on pilot scale and then

5 industrial scale batches to make sure that we're

6 yielding the product that we anticipate, and

7 that's proven through finished product testing as

8 well as in process testing.

9 As far as the individual technique for

10 dilution is concerned, that process is also

11 validated and depending on the exact nature of the

12 processes being undertaken, it may involve the

13 original starting material or it may involve

14 surrogates.

15 DR. WHYTE: Thank you. So we are just a

16 minute behind schedule. The agenda has us

17 concluding at 2:25. It is 2:26. We will resume

18 in 15 minutes, so please come back at that time.

19 Thank you.

20 (Off the record at approximately 2:15

21 p.m.)

22 (Recess.)

248 1 (Back on the record at approximately

2 2:25 p.m.)

3 DR. WHYTE: Okay. We're coming along

4 the home stretch. Our next speaker is Barbara

5 Kochanowski from the Consumer Healthcare Products

6 Association.

7 MS. KOCHANOWSKI: Thank you and good

8 afternoon. I'm Barbara Kochanowski, Vice

9 President of Regulatory and Scientific Affairs for

10 the Consumer Healthcare Products Association.

11 CHPA is the trade association

12 representing the manufacturers of over the counter

13 medicines and dietary supplements. We have more

14 than 80 manufacturer members and about 10% of

15 these market homeopathic medicines.

16 Our members include both branded and

17 private label companies, large and small, publicly

18 held and privately held. What brings them

19 together is a shared commitment to strengthen the

20 industry through science education and advocacy.

21 Today I'll be addressing four of the

22 questions FDA posed in the announcement for this

249 1 meeting. I'll share some consumer data and

2 insights regarding OTC medicines, including

3 homeopathic products. I'll also comment on the

4 safety of homeopathic products and the current

5 regulatory framework.

6 Seen through a consumers eyes, a broad

7 range of products are helpful as people take care

8 of their own health needs. Consumers site many

9 reasons for OTC healthcare product usage,

10 including 24/7 availability, greater control of

11 their health, and cost savings.

12 Americans demand a range of options

13 among products used to self treat their health

14 conditions. Why? Individual preference for

15 ingredients, dose forms, and formulations vary.

16 We see individual variability in

17 response to treatments. Some medicines in a

18 product category may be contra indicated for

19 certain populations, while others are not.

20 All of these factors can lead to

21 differences in satisfaction with available

22 treatment options. Research shows consumers

250 1 report very responsible attitudes towards OTC

2 medicines. Most take an active role in their

3 healthcare. They are confident in their ability

4 to use OTC medicines and know that the medicines

5 work for them.

6 And, most U.S. adults are comfortable

7 treating minor illnesses before seeking

8 professional care. In fact, they prefer self

9 treatment.

10 FDA has two questions about consumer

11 knowledge and attitudes about homeopathic

12 medicines. CHPA recently conducted some consumer

13 research to better understand consumer knowledge

14 about homeopathic products.

15 This was a telephone survey among 1,000

16 U.S. adults. We'll share the full results in our

17 written comments as they came in after the slides

18 were prepared. Key findings include that

19 consumers demand a range of treatment options.

20 Seventy-four percent of those surveyed agree that

21 when making a decision about what products to buy

22 to treat their conditions, they would like even

251 1 more options, and 79% of consumers agree that

2 finding a product that works for them means they

3 need multiple choices.

4 When asked about familiarity with

5 homeopathic products, one quarter of respondents

6 were extremely or very familiar. One quarter were

7 somewhat familiar, and one half were a little or

8 not familiar. Thirty-eight percent of the

9 respondents said they had tried homeopathic

10 products, and not surprisingly, those who were

11 most familiar with homeopathic products were the

12 most frequent users.

13 Doctors and online websites are by far

14 the major sources of information about medical

15 treatments, with doctors being seen as the source

16 of the most reliable information.

17 We know from many research studies that

18 consumers shop by indications and the symptoms

19 they intend to treat. As such, it's unlikely that

20 consumers look specifically -- or that most

21 consumers look specifically -- for homeopathic

22 products, but rather look for products that give

252 1 them a range of choices to treat their symptoms.

2 CHPA strives to provide consumers with

3 accurate information about all OTC medicines. Our

4 consumer facing website under the label of

5 KnowYourOTCs.org is one source of information for

6 consumers about OTC medicines, including

7 homeopathic products.

8 CHPA is also hosting a webinar, upcoming

9 soon, on homeopathy, with a focus on regulations

10 and compliance. This is available to our members

11 and non members. This material will be archived

12 for future viewing if anyone is interested in the

13 topic.

14 FDA asked about data sources to better

15 understand homeopathic products. The American

16 Association of Poison Control Centers, NPDS (ph)

17 database is one such source.

18 Dr. Krenzelok has already spoken about

19 these data earlier today, which covered the span

20 of 2006 to 2013. That research was funded by

21 CHPA. The data show that homeopathic products have

22 a very favorable safety profile, with low overall

253 1 exposures, and with low or no health effects. As

2 is the case with all medicines, though, there's an

3 opportunity to reduce accidental and intentional

4 exposures.

5 And as a follow-up, I don't think it was

6 stated earlier -- Rocky Mountain Poison Center is

7 going to be purchasing the additional case level

8 data that they'll be able to do a much more in

9 depth analysis of the case reported in that data

10 system, and that report, we hope to be able to

11 submit by the June 22nd deadline. But regardless,

12 they will be doing that.

13 CHPA supports the regulatory framework

14 for homeopathic drug products, which are regulated

15 in many ways like allopathic OTC drugs. We

16 believe that the FDA compliance policy guide has

17 been successful in supporting FDA's public health

18 mission, and appreciate the opportunity to work

19 with FDA in reviewing it.

20 Homeopathic drugs have been subject to

21 regulation under the federal FTNC Act since 1938.

22 Manufacturers of homeopathic medicines are subject

254 1 to routine inspections, and the CPG requires

2 manufacturers to register with the FDA and list

3 their drug products.

4 Controls like CGMP's serious adverse

5 event reporting, standardized labeling, and

6 compendia standards, are all in place to assure

7 quality and safe use.

8 In summary, to the consumer, homeopathic

9 medicines are one segment of OTC medicines.

10 Consumers see great value in OTC medicines for

11 treating minor ailments because they provide cost

12 effective, accessible solutions to self treatable

13 conditions.

14 Consumers demand a range of choices to

15 treat their conditions, and they select OTC

16 medicines based on indication and symptoms, not on

17 regulatory classification. Nearly 40% of

18 consumers report having tried homeopathic

19 medicines, and homeopathic products have a very

20 favorable safety profile.

21 The current regulatory framework meets

22 the needs of consumer access and ensures standards

255 1 of quality and safety by homeopathic drug

2 manufacturers. Where products are not following

3 the CPG, FDA has the ability to act and to act

4 swiftly.

5 I thank the FDA for this opportunity to

6 present on behalf of our members.

7 DR. WHYTE: Thank you, Barbara. Barbara

8 noted she was here one of my first days I started,

9 so she said she was glad that I'm still here, so

10 thank you. Thank you, Barbara.

11 So, maybe we'll start the five minutes

12 of questions and we -- Kate just put -- at the

13 last minute. We'll start with Kate.

14 DR. BENT: Can you clarify what you mean

15 about standardized labeling? It's on your

16 slide 11.

17 MS. KOCHANOWSKI: I think you heard form

18 Mark Phillips. I'm not quite sure of the last

19 speaker, but he talked about having the

20 ingredients -- the warnings -- the drug facts type

21 labeling for categorization of the different

22 elements of a label on homeopathic medicines.

256 1 DR. BENT: And are the label dilutions

2 standardized?

3 MS. KOCHANOWSKI: I'm sorry, I don't

4 know.

5 MS. LIPPMANN: Can you elaborate a bit

6 on what you believe to be the understanding that

7 consumers have about homeopathy and what it is?

8 So, for example, not just that a product

9 is homeopathic, but do they understand the issue

10 of dilutions and that there might not be any trace

11 of a pharmacologically active ingredient.

12 MS. KOCHANOWSKI: Good question. Our

13 research that we did very quickly in preparation for

14 the hearing was really the first opportunity we've

15 had to talk to consumers at all about homeopathic

16 products in recent times, and we gave a short

17 definition of homeopathic products as part of the

18 survey.

19 So when you see about 40% of consumers

20 responded they had tried them, they at least had

21 some information that we provided in the survey,

22 but we didn't do anything other than that to probe

257 1 their knowledge level.

2 MS. LIPPMANN: So you don't know, for

3 example, if they understand homeopathy to be

4 different or the same as natural medicine, say?

5 MS. KOCHANOWSKI: We didn't test that in

6 the survey.

7 MS. LIPPMANN: Thanks.

8 DR. LOSTRITTO: I'm going to follow up

9 on that. Your organization deals with a number of

10 consumer healthcare products, and I assume your

11 organization has an interest as part of its

12 mission to facilitate choice through education and

13 clarity of labeling.

14 Having said that, what do you see as the

15 balance between labeling delineation by different

16 types -- I've been discussing here five

17 medicinals, RX, OT switches, um, homeopathic

18 products.

19 Product placement, labeling, and how you

20 would use that -- how do you envision that -- to

21 optimize choice of the right thing that the

22 patient is seeking?

258 1 MS. KOCHANOWSKI: That's probably the

2 million dollar question, isn't it? That's a great

3 question, and I think what we're hearing at the

4 meeting is that there are opportunities to

5 potentially clarify labeling, but first to better

6 understand what consumers are actually looking

7 for, and how they're reading those labels.

8 All of our research, historically, has

9 shown they shop by symptoms, and they're looking

10 to treat a certain condition. Beyond that, we

11 need to answer some of those questions to be able

12 to say, "Does it make sense to change anything?"

13 MR. PACE: With respect to abuses of the

14 CPG, can you comment on whether you're aware of

15 firms or instances where firms may be using the

16 CPG to market a product as homeopathic when they

17 don't -- maybe not -- when they maybe don't need

18 an OTC monograph, or otherwise be legally

19 marketed.

20 MS. KOCHANOWSKI: You know, I think you

21 heard the former group talk about the outliers.

22 I'm not aware of any specific examples, and we

259 1 would certainly not support that.

2 DR. WHYTE: Any other questions? All

3 right. We'll welcome now Peggy O'Mara to the

4 podium.

5 MS. O'MARA: How much can I do with

6 this? Okay. I'm short. All right. Let me get

7 this out of here. I'm sorry.

8 My name is Peggy O'Mara. Good afternoon

9 everyone -- and I have no financial interest

10 related to this hearing.

11 As an award winning journalist, I have

12 been covering natural family living for over 30

13 years. I was the editor and publisher of

14 Mothering Magazine from 1980 to 2011, and in 1995,

15 I founded Mothering.com, the largest online

16 community of naturally minded parents. In 2013, I

17 founded PeggyOMara.com, where I continue to cover

18 family health.

19 In these roles, I possess a broad

20 knowledge of consumer attitudes toward and use of

21 homeopathic products, especially as related to

22 pregnancy, birth, and child care.

260 1 I serve on the advisory boards of

2 Attachment Parenting International, Best for

3 Babes, Holistic Mom's Network, Infant Massage

4 U.S.A., Intact American, and Oak Meadow. I'm a

5 mother of four adult children, and the grandmother

6 of three.

7 My own introduction in homeopathy

8 occurred in the early 1980's when as the editor of

9 Mothering Magazine I published an article by a

10 homeopathic physician. Soon thereafter I visited

11 a homeopathic pharmacy to look for over the

12 counter drugs to sooth the minor illnesses of my

13 four children.

14 As a natural living pioneer, I sought

15 out alternative healthcare for my family, not only

16 because of my inclination, but also because I am

17 of the first generation of parents to become aware

18 of the potential overuse of antibiotics.

19 Today I will address FDA's questions;

20 number one, about consumer attitudes, and number

21 eight about labeling.

22 I'll begin with question number one. In

261 1 the early 2000's, Whole Foods Market did an

2 internal survey and determined it is women who buy

3 the majority of their products, both for

4 themselves and for their families, and that women

5 first become interested in natural products when

6 they start a family.

7 As new mothers, women become more

8 concerned about they put into their bodies and

9 what they put into their children's bodies. They

10 look for safe and gentle products and their

11 concerns lead them to become consumers of

12 homeopathy.

13 Homeopathic consumers respect allopathic

14 medicine, but not all symptoms require a visit to

15 the doctor's office or a prescription.

16 When I was the mother of four young

17 children, I wanted effective and affordable

18 products to sooth my children's minor ailments and

19 support their healing. Like young parents of

20 today, when I look for over the counter products,

21 I want ones that are not only pure and safe, but

22 also accessible and easy to use.

262 1 There are several reasons that consumers

2 choose homeopathic products, and the first is that

3 homeopathic products are affordable. The cost,

4 for example, ranges from $7.00 to $15.00, and

5 homeopathic products are easily available online

6 at many websites, including Amazon.com, as well at

7 local natural grocery stores and pharmacies.

8 Mother's also find homeopathic drugs easy to use

9 because children like their taste and do not

10 resist taking them.

11 Certainly, the biggest reason that

12 parents use homeopathic products is because they

13 work. Young mothers of today, including my

14 daughter and my daughter-in-law, have great

15 enthusiasm for homeopathic teething tablets, for

16 example, and their use has steadily grown in

17 recent years through word of mouth.

18 Mothers recommend them to each other,

19 simply because they work so well. Mother's want

20 safe and gentle products. They worry when they

21 hear about product recalls of over the counter

22 cough and cold medicines for children, and many

263 1 look to homeopathy as an alternative because they

2 trust homeopathic products to be safe and

3 effective and gentle.

4 Parents also look to homeopathy as a

5 safe and gentle first line of defense for upper

6 respiratory illnesses -- for upper respiratory

7 illnesses in their children, and they want to be

8 prudent about giving their children antibiotics

9 unless absolutely necessary.

10 Over the last several decades there has

11 been a profound shift in the ways consumers

12 participate in their healthcare. They are

13 increasingly taking a proactive and holistic

14 approach to health and wellness. In fact, the

15 concepts of health and healthcare are moving

16 toward the notion of personalized health

17 maintenance.

18 Consumers of homeopathy are interested

19 in this kind of participatory medicine because it

20 increases their sense of self-determination, and

21 by example, their children's.

22 As a young woman, I read the book,

264 1 Homeopathic Medicine at Home, and through its use

2 became a better mother because I began to observe

3 the symptoms of my children in a more

4 comprehensive way.

5 For example, before I read the book I

6 thought that a cough was just a cough, but

7 homeopathy has taught me that there are many

8 different types of coughs, and in wanting to

9 differentiate between them I believe I have become

10 a better mother and more helpful to my children

11 because I provided them an example of home self

12 care -- of home self care that they have continued

13 with their own families.

14 U.S. Consumer's use of homeopathic

15 medicine has also been influenced by the fact that

16 we have become a world community. U.S. parents

17 know what parents in other countries are doing and

18 it gives them confidence to try new things.

19 They are influenced by the fact that

20 62.5% of French mothers use homeopathic drugs and

21 practice -- and pediatric homeopathy is very

22 popular, both in Germany, and in France, and in

265 1 other parts of Europe. Because of their

2 fascination with Princess Kate Middleton, young

3 mothers in the U.S. are intrigued when they hear

4 that England's royal family has been using

5 homeopathy for generations.

6 Apparently, mothers all over the world

7 use homeopathic drugs to sooth their children's

8 acute conditions like colds, coughs, flu, fevers,

9 and teething. They find them helpful for minor

10 sports injuries, for occasional sleeplessness and

11 anxiety, for over stimulation, seasonal allergies,

12 and other every day ailments.

13 In addition, the internet has made it

14 easy for mothers to get information about

15 homeopathy. Mothering.com is the premiere website

16 for natural family living, and with over 240,000

17 members, the largest online community for

18 naturally minded parents.

19 On Mothering.com, for example, there are

20 over 100 links to articles and discussion threads

21 about homeopathy, and discussion threads include

22 conversations about homeopathy for ailments like

266 1 morning sickness, teething, growing pains, cough,

2 sleeplessness, colds, nasal congestion, and fever,

3 among others.

4 As the Editor and Publisher of Mothering

5 Magazine for over 30 years, I have witnessed the

6 evolution of homeopathy from alternative medicine,

7 to complimentary medicine, to integrative

8 medicine.

9 When I was a young parent, there were no

10 health food stores or natural food grocery stores,

11 so we made our own alternative products. Today,

12 natural and organic food is the fastest growing

13 sector of the American food economy, and every

14 year the natural and organics product industry

15 grows in double digits. Along with natural

16 products and natural food, homeopathy has become

17 mainstream.

18 Next, I would like to address FDA's

19 question number eight. I find the labeling on

20 homeopathic products to be adequate. I appreciate

21 that the label lists the uses for the remedy

22 because it expands my knowledge, and in fact, I

267 1 usually go into a store looking for a specific

2 remedy I have researched myself.

3 In my opinion, gaps in adequate product

4 information exists within some medical practices,

5 but not at the retail level, for the consumers. I

6 would appreciate it allopathic and other

7 healthcare practitioners were more versed in

8 homeopathy, because it is often an excellent

9 compliment to their care.

10 For example, I would have welcomed

11 recommendations for homeopathic drugs to ease my

12 pain when I recently had x-rays and follow-up

13 physical therapy for arthritis.

14 In conclusion, many consumers today are

15 interested in self care and leading a toxic free

16 lifestyle, so they look for a repertoire of

17 natural products to bring relief to themselves and

18 their loved ones. Parents want safe, effective,

19 affordable, and easily accessible products for

20 everyday ailments, and homeopathic products

21 provide this.

22 I hope that your deliberations will

268 1 result in the continued ease of access to

2 homeopathy that three generations of my family,

3 and thousands of my readers and online community

4 members have enjoyed. Thank you very much for the

5 opportunity to speak to you today.

6 DR. WHYTE: Thank you, Peggy, for

7 sharing your story. I didn't think we'd hear

8 about Kate Middleton today.

9 MS. O'MARA: I had to throw her in.

10 She's very --

11 DR. WHYTE: That was interesting. I

12 forgot my question on her, but okay. So let's see

13 if the panelists have any questions. And Daddy's

14 care about safe medicines, too, so -- it's always

15 Mommy, Mommy, Mommy. Okay. All right. Let's --

16 yeah, Mommy and Me classes. There's Daddy and Me,

17 too. Okay. I have a young child at home.

18 (Laughter.)

19 DR. WHYTE: Any questions?

20 (No audible response.)

21 DR. WHYTE: All right. Well, thank you,

22 Peggy.

269 1 MS. O'MARA: Thanks.

2 DR. WHYTE: All right. Next, we're

3 going to have Luana Colloca. Did I say your name

4 correctly? Colloca. I apologize. From

5 University of Maryland in Baltimore.

6 DR. COLLOCA: Good afternoon. I would

7 like to thank the FDA for the invitation, and it

8 is -- okay, a little bit about me. I am a

9 physician with a PhD in neuroscience and a

10 Master's in bioethics, and during the last two

11 decades I was working on mechanismal (ph) placebo

12 effects.

13 Today we were talking several times

14 about placebo effects, but never were mentioned

15 the mechanism that aligned this phenomenon, so

16 that is a great opportunity for me to show our --

17 it's important to see that expectancy, motivation,

18 and the placebo mechanism when we take into

19 account any interventions.

20 So, the goal will be to show a little

21 bit of neurobiology related to this mechanism, how

22 important clinically to consider if placebo

270 1 effects, and finally discuss with you the

2 legitimacy of intervention that may work by virtue

3 of a placebo mechanism.

4 So, placebo. A placebo, per se, is a

5 term that comes from the Bible. Placebo

6 (inaudible) -- from Latin -- and the translation

7 means "I shall (inaudible.)"

8 But it's very important to distinguish

9 between placebo effects and placebo responses.

10 Placebo effects are related to a neurobiological -

11 - a clinically relevant phenomenon -- and we are

12 able to distinguish between placebo effects and

13 placebo responses when we have a (inaudible.)

14 So a placebo effect will be something different

15 from bias, a regulation to the mean, naturally

16 studied, co-intervention, and so on. Conversely,

17 the placebo response per se can be related to all

18 of these effects together because we don't have a

19 (inaudible.)

20 So, just to summarize, this is an example where we

21 are able to see that a proportion of any benefit

22 we observe in clinic can be related to different

271 1 phenomenon and just a little bit of this benefit

2 eventually is related to placebo effects. And the

3 magnitude of this kind of phenomenon varies

4 tremendously across different conditions and

5 disease.

6 So, it's very important to consider that

7 when we talk about placebo effects we are not

8 talking about effects of sugar pills or saline

9 solution. Every time we use an intervention,

10 there is a placebo component related to the

11 (inaudible) and the (inaudible) around any

12 patient, and it's interesting that any time we use

13 an intervention that is conventional or

14 alternative, we have the combination of both the

15 effects.

16 And that is an example where we show

17 that -- for example, for pain, it's interesting

18 that any time we experience relief, this kind of

19 relief is derived by specific pharmecodenomic (ph)

20 component, and some other component that I call

21 here, expectancy driven effects.

22 And just an example, I was still

272 1 (inaudible) the student, and we start to use this

2 model where morphine was delivered through a

3 different way. (Inaudible) administration versus

4 open administration. For (inaudible)

5 administration, you can see from the cartoon we

6 use a pump of infusion to (inaudible) deliver

7 morphine.

8 Conversely, for the open administration,

9 the patient would inform about the time of

10 delivering of our medication, and you can see from

11 these results that even the effects of morphine

12 changed dramatically when we use an (inaudible)

13 versus open administration.

14 So, we measure pain, in this case, in

15 patient in post-operative surgery, and we use a

16 medical rating scale, and you can see the broken

17 line shows the time of administration for ten

18 milligrams of morphine to manage post operative

19 pain.

20 In blue, I show the effects of an open-

21 administration of morphine. In red, the

22 (inaudible) administration of morphine. The

273 1 difference in exactly the same dose of morphine is

2 related to expectancy and placebo effects.

3 It's also interesting that this

4 phenomenon -- it's true in the opposite way.

5 Where was negative expectancy driving adverse

6 event, or less if (inaudible) issues the drug.

7 So, in fact, when we look at morphine --

8 and in this case we showed interruption of

9 morphine by informing our patient, now we are

10 stopping, in blue, you can see that there is an

11 increase of pain.

12 Conversely, when we interrupt morphine

13 but patients are not aware about this because the

14 interruption was managed by a computer, there is

15 no change in pain perception. That is the power

16 of expectancy in managing our perception of

17 symptom like pain.

18 And this kind of effects are not true

19 only for morphine, we explored open administration

20 of different kind of pain killers. You can see

21 that both opiods and non-opiods, like (inaudible,)

22 tramadone (ph,) catorelcok(ph,) metamisone (ph,)

274 1 are very strongly modulated by expectancy.

2 Again, in green we show the open

3 administration where there is the combination of

4 both the component, pharmocodenomic (ph) specific

5 component, plus placebo effects. And in red, when

6 the same dose was managed by a pump of infusion --

7 so we, in the lab or in the clinical setting,

8 silent expectancy.

9 It's also interesting that words, per

10 se, can modulate the perception of the symptoms.

11 In this case, women at term of their pregnancy and

12 ready for delivery were treated with epidural

13 anesthesia, and they were informed differently

14 during the procedure.

15 Randomization, through two different

16 disclosures -- group one was told, "You are going

17 to feel a big, big sting. This is the worst part

18 of the procedure." Group two was told, "We are

19 going to give you a local anesthetic that will

20 numb the area and you will be comfortable during

21 the procedure."

22 So, group two, slightly differently

275 1 informed, you can see that there is a positive

2 component, an anticipation of the benefit related

3 to the administration of the anesthetic drug. And

4 in this case, when a blind clinician was entering

5 into the room and assessed the pain related to the

6 procedure, you can see that group two reports an

7 experience of less pain.

8 So, based on this observation, we

9 suggested to educate any practitioners and

10 patients about the possible effects of placebo

11 processes, but also tailoring the information

12 delivery process to the needs of the patient, and

13 frame the disclosure processes, and pay attention

14 to any kind of information we deliver to our

15 patient.

16 But, the goal of this part (inaudible) -

17 - who was first let you know that placebo effects

18 depend upon the activation of specific

19 physiological mechanisms, but most importantly for

20 today, I think that this kind of research may

21 provide a hint to reconsider the efficacy of any

22 intervention and treatment that may work primarily

276 1 by placebo mechanisms.

2 And, you know, as we assess the

3 (inaudible) treatment, any kind of treatment, and

4 the question is, if an intervention lacks specific

5 efficacy, is it still appropriate to recommend it

6 in daily clinical practice?

7 And I'm not talking very much about

8 homeopathy, but I want to present three different

9 examples to show how placebo effects can be

10 relevant and our interest is to think about

11 efficacy based on this knowledge.

12 Let's start with supplemental.

13 Supplemental derives from (inaudible) -- and it's

14 mostly used to treat symptoms related to benign

15 (inaudible.) So, when we compare the effects of

16 this alternative treatment with conventional

17 treatment in a large population -- in this case

18 the researcher compared Saw Palmetto with

19 finasteride, and you can see that there is very

20 compatible efficacy for both of the treatments as

21 was when compared supplemental with tamsulosin.

22 So, when we look at cost, supplemental costs much

277 1 less than both the conventional treatment.

2 And let's provide another example. Non-

3 invasive vertebroplasty -- for those of you who

4 are not familiar with the procedure, that is a

5 surgery that is suggested for a patient with

6 osteoporosis and pain related to fracture in the

7 spine.

8 So, interestingly, there have been

9 published very interesting paper related to this

10 procedure and I will show to you that they include

11 a sham (ph) surgery. So the sham surgery consists

12 in exactly the same procedure, but without

13 injecting (inaudible.)

14 The goal was to try to understand if

15 vertebroplasty per se can modulate pain perception

16 and manage pain over time.

17 Interestingly, two randomized clinical

18 trials published in New England Journal of

19 Medicine and one open label trial published in

20 Lancent show no difference between sham and true

21 surgery, but with is important, both are very good

22 in managing pain and report improvement of the

278 1 pain measured at the time point. So, the question

2 is then, is it acceptable to recommend this

3 intervention based on what we have learned through

4 the clinical trial?

5 So, in this case, we can look at the

6 risk benefit cost to provide. In (inaudible) --

7 there are no complications related to the sham

8 surgery, and both groups show the same occurrence

9 of adverse events like fractures. In terms of the

10 benefit, both true and sham vertebroplasty reduced

11 pain in patients. In terms of cost, patients

12 treated with vertebroplasty gained on average 120

13 pain free days.

14 Now, a little bit of homeopathy. Is the

15 benefit of homeopathy a placebo effect? Well,

16 today we have learned a lot about this with

17 comprehensive talk about current knowledge. I

18 just would like to show two (inaudible) and to

19 review a delayed metanalysis (ph) actually. It

20 related to homeopathy.

21 The one published about ten years ago in

22 Lancet that we discussed already today show that

279 1 large trials of higher quality, the observation

2 for homeopathy was 0.88 as compared to 0.58 for

3 conventional medicine.

4 However, if we look in a sort of

5 condition where the expectancy are quite small

6 because of the intrinsic nature of, you know,

7 these averages included in the metanalysis, like

8 animals, there was no robust evidence that

9 homeopathy is distinguishable from placebo

10 effects.

11 Therefore, there are at least three

12 questions of interest. At interventions, working

13 by virtue of placebo responses or effects,

14 clinically and medically acceptable, should the

15 clinician or any other health practitioner

16 recommend these interventions in addition, but not

17 instead of, conventional treatment.

18 If intervention with equal efficacy, and

19 usual care are not given, do we deprive our

20 patients of potential benefit?

21 They suggest three answers, but I'm open

22 to discuss with you -- it is acceptable to

280 1 recommend an intervention with clear favorable

2 risk/benefit to cost/provide. In terms of

3 professional integrity, it may remain a potential

4 conflict of interest to the principle of evidence

5 based medicine, and ultimately patients deserve to

6 be informed about our current knowledge, and

7 eventually any lack of specific efficacy and a

8 potential for a specific placebo responses.

9 And I would like to thank you for your

10 attention, and those who are interested to learn

11 more about the neurobiology related to placebo

12 effects, we published during the last two years

13 these three books.

14 DR. WHYTE: Thank you very much, and

15 we'll start with our questions.

16 DR. LOSTRITTO: Thank you very much. I

17 have two questions. I think they're relatively

18 quick.

19 One, on the open versus the closed

20 administration of an analgesic, do you know if

21 there was a difference in healthcare contact at

22 the patient's bedside in the closed versus the

281 1 open, or the hidden versus the open?

2 DR. COLLOCA: We didn't enforce exactly

3 the same amount of healthcare contact before the

4 treatment, but of course there is a difference

5 when we have the open scenario, where of course a

6 physician or a nurse informs the patient, and the

7 psychosocial context around the patient is then

8 researched.

9 However, this study has been duplicated

10 with (inaudible) and in this case normal

11 participants were receiving the (inaudible) with

12 open and even administration of the same drug, and

13 it's interesting that there is a different

14 modulation of a specific area of the brain related

15 to being aware of receiving the treatment versus

16 not.

17 DR. LOSTRITTO: You also showed some

18 very interesting examples of sham surgery versus,

19 you know, real surgery, and so forth, and you sort

20 of stopped short in your presentation. I'm going

21 to ask you to go a step further.

22 Are you implying, either implicitly or

282 1 explicitly, that the placebo effect is the

2 operative mechanism for homeopathy, and if so, can

3 you explain where your conclusion is drawn from?

4 DR. COLLOCA: Sure. I have to do my

5 disclosure. I didn't do research with homeopathy.

6 What I did was a search of the literature to learn

7 more about this phenomenon.

8 But today we are talking, and in

9 general, people who work in this field know that

10 expectancy and motivation of a patient are

11 relevant, and my research and other colleagues who

12 work in this field show our expectancy can really

13 produce neurobiological change.

14 So, I expect that, like for surgery or

15 alternative treatment, tests for less conventional

16 medicine like morphine or (inaudible,) there must

17 be a placebo component, and I expect that this

18 placebo component is quite strong.

19 So, to be careful in addressing the

20 question that I tried to skip -- is homeopathy an

21 example of a placebo effect? It can be, but it's

22 very important to understand in which this is,

283 1 which condition, and eventually to try to take

2 into account patient expectation and motivation.

3 DR. WHYTE: Dr. Nelson?

4 DR. NELSON: I'm going to take a risk

5 here. This may sound more like a comment than a

6 question, but I'll ask you to comment on my

7 comment then as the question.

8 I'm struck by the language that we're

9 all using in different ways. So, natural and

10 homeopathic, at times, seems to be lumped

11 together. I'm not surprised. If you look at the

12 history of the development of allopathic

13 medications, a lot of them come from natural

14 products. Digitalis would be a good example.

15 And so I'd -- you know, the Saw Palmetto

16 example is not surprising to me necessarily. I

17 wasn't aware of that research, and then I decided

18 since I'm sitting here with my laptop to Google

19 Saw Palmetto and homeopathy, and up comes -- and I

20 have no idea if this is reputable -- "mother

21 tincture, ten to 30 drops, third potency often

22 better for precisely the treatment of benign

284 1 prosthetic hypertrophy."

2 And so, I guess, you know, these

3 categories -- we seem to be using them in

4 different ways that are often in my mind not clear

5 if we're being precise, and that bothers me.

6 You know, there is -- the reason we pick

7 -- I mean, a placebo is meant to be an inert

8 substance so I'm sitting here thinking, well, what

9 would be the placebo for a homeopathic trial?

10 Would it be, you know, the mother tincture?

11 DR. COLLOCA: A solution without any

12 component.

13 DR. LOSTRITTO: No, I -- well, but I

14 don't know what it is, and so that -- it would

15 really have to be specific. It's just -- I guess

16 the terminology -- I'm beginning to feel that

17 we're being a bit loose when we talk about natural

18 versus homeopathic versus allopathic.

19 We really need to be much more specific

20 in those details, and I guess I -- whatever

21 comment you have on my comment.

22 DR. COLLOCA: I can comment on this and

285 1 say that from an epistemological -- you know,

2 toxonimy (ph) point of view, it's always helpful

3 to have very clear determination, but that is not

4 necessarily always easy.

5 And, from my perspective, homeopathy is

6 a good case where it's possible to understand the

7 placebo component quite well because, as compared

8 to other procedures like vertebroplasy or some

9 other more difficult intervention to -- you know,

10 in terms of cost or in terms of (inaudible) to

11 control.

12 Homeopathy, at least, I represent a case

13 where it is possible to study the placebo

14 component, and I agree with you that it's always

15 good to talk good terminology to try to narrow the

16 limits of research and knowledge.

17 DR. WHYTE: Kate, did you have a

18 question?

19 DR. BENT: I do. One of your concluding

20 remarks addressed transparency in communication

21 with patients about specific efficacy and

22 unspecific responses.

286 1 So, are you aware of research that looks

2 at healthcare patient communication specifically

3 around placebo or around expectancy, and around

4 health literacy in homeopathic --

5 DR. COLLOCA: I had the opportunity to

6 work on this -- work on placebo effects and

7 ethical aspects when I was at NIH.

8 We were running a lot of research

9 looking at how disclosure can drive (inaudible) --

10 as well can drive adverse events and placebo

11 effects, and I really want to emphasize the need

12 to explain transparently to patients, you know,

13 our knowledge, and eventually the lack of

14 knowledge sometimes.

15 And, of course, this may create a sort

16 of reassessment of their expectancy, but I think

17 it's ethically and really important to inform

18 patients so that they can make a good decision and

19 progress.

20 DR. WHYTE: Thank you. Okay. Next we

21 will hear from Alyssa Wostrel from the Integrative

22 Health Policy Consortium.

287 1 MS. WOSTREL: Thank you, Dr. Whyte and

2 panalists. Thank you for the opportunity to speak

3 today. My name is Alyssa Wostrel and I am the

4 Executive Director of the Integrative Health

5 Policy Consortium, or IHPC.

6 As background, IHPC is a national non-

7 profit, 501-C4, created in 2001 as requested by

8 Congressional members who saw a consensus voice in

9 complementary and integrative healthcare for

10 legislators, policy makers, and federal agencies.

11 Our mission is to advocate for an

12 integrative healthcare system with equal access to

13 the full range of health oriented, person

14 centered, regulated healthcare professionals.

15 IHPC represents 16 organizations and

16 educational institutions, over 400,000 licensed

17 and certified providers, including chiropractors,

18 acupuncturists, holistic nurses, certified

19 professional midwives, massage therapists,

20 naturopathic physicians, and conventional

21 physicians trained in integrative practice.

22 They provide clinical care services to

288 1 millions of Americans each year. IHPC is here to

2 assure safety and quality in complementary

3 alternative medicine. With assured safety and

4 quality we expand the effective choices for

5 doctors and patients in healthcare.

6 Now, a quick word about my background.

7 Prior to joining IHPC as Executive Director, I

8 served as an Executive and a consultant with

9 several homeopathic manufacturing companies. I

10 interacted with thousands of licensed

11 practitioners who used homeopathic products for

12 their patients regarding product use and medical

13 education programming.

14 I coordinated with quality assurance and

15 quality control departments to assure product

16 labeling compliance with labeling regulations in

17 the compliance policy guide. I always consider

18 the FDA an important guide in promoting the safety

19 of the public health.

20 Today, issues about safety and quality

21 will inform the three key agenda questions that I

22 will address. Safety and quality of homeopathic

289 1 products is a constant in our professions. Safety

2 and quality is a focus of advocacy by IHPC. It is

3 through the lens of safety and quality that I

4 deliver my remarks today.

5 To the question, what are consumer and

6 healthcare provider attitudes towards human drug

7 and biological products labeled as homeopathic?

8 IHPC has the following answer; positive consumer

9 attitudes about high quality, safe, homeopathic

10 products, can be seen through quantity and

11 frequency of use.

12 Homeopathic products accounted for an

13 estimated one billion dollars in out of pocket

14 expenditures in the U.S. in 2012, according to

15 research by Mintel (ph.) A 2008 NCAM (ph) survey

16 listed homeopathy in the top ten most utilized CAM

17 therapies.

18 A Stanford study of CAM use among the

19 fastest growing segment of the population found

20 that 5.8 percent of seniors surveyed use

21 homeopathy and experienced greater symptom relief

22 compared to other CAM options. A 2014 survey of

290 1 homeopathic patients noted efficacy and safety as

2 the top two, quote, "best liked attributes of

3 homeopathy."

4 Providers that IHPC represents have

5 favorable attitudes toward both availability of

6 homeopathic services through trained and

7 credentialed practitioners and patient access to

8 homeopathic products.

9 These providers incorporate safe, high

10 quality, homeopathy in patient care during

11 consultations, and also for ongoing patient's

12 healthcare. Therefore, access to homeopathic

13 products is important as a therapeutic choice for

14 both the provider and the consumer.

15 Access to the licensed or certified

16 healthcare provider of one's choice is a central

17 tenant of Section 2706, the non discrimination

18 provision of the Affordable Care Act. IHPC

19 advocates for the full implementation of Section

20 2706 through Cover My Care, a consumer facing

21 initiative.

22 The FDA's effective guidance of a

291 1 manufacturing, labeling, marketing, and sales of

2 homeopathic products has been in place since 1938.

3 Compliance requires that manufacturers must

4 register with the FDA and are subject to FDA

5 inspections. IHPC fully supports this guidance.

6 The healthcare providers represented by

7 IHPC, who practice homeopathy, and who refer to

8 homeopathic practitioners, understand that

9 individual homeopathic ingredients marketed for

10 sale in the U.S. have been thoroughly reviewed.

11 They have been reviewed for homeopathic

12 efficacy, toxicology, adverse effects, and

13 clinical use, by the Homeopathic Pharmacopeia

14 Convention of the U.S. This informs the attitudes

15 of these providers that utilization of homeopathic

16 products is in accordance with best practices for

17 safety and effectiveness.

18 This rigorous review by HPCUS, guided by

19 the FDA, has been an essential in safety and

20 quality of homeopathic products.

21 My professional experience in this field

22 assures me that the current regulatory system,

292 1 based on the FDA compliance policy guide, has been

2 effective for safely regulating homeopathic

3 products.

4 To the question, "What data sources can

5 be identified or shared with FDA so that the

6 Agency can better assess the risks and benefits of

7 drug and biological products labeled as

8 homeopathic?"

9 IHPC has the following answer:

10 References from the World Health

11 Organization and the Swiss Government Report are

12 suggested. Both address similar question to those

13 the FDA is asking in this hearing. Links to

14 documents are provided in our submission.

15 The IHPC can be utilized by the FDA as

16 an information source to engage with the leaders

17 in complimentary and integrative healthcare in the

18 U.S. to access recommendations of data to review.

19 Such an information channel can create a center

20 for FDA discussions with providers about real time

21 safe usage of effective quality products in a

22 clinical or therapeutic setting. IHPC's consumer

293 1 based site, Cover My Care, may also provide a

2 similar channel to patient populations.

3 In order to add to the FDA's already

4 substantial understanding of homeopathy, and to

5 foster clarity, the FDA could consider having a

6 homeopathic expert on staff to serve as a liaison

7 with the homeopathic community.

8 And finally, to the questions, "Do

9 consumers and healthcare providers have adequate

10 information to make informed decisions about drug

11 products labeled as homeopathic?" IHPC has the

12 following answer:

13 Regarding healthcare providers, the

14 breadth of licensed and certified providers and

15 their patients who safely use homeopathic products

16 have been well served for many decades. This

17 service is underpinned by the robust educational

18 standards of training, licensing, and certifying

19 bodies, in homeopathic education, and their

20 professional development, symposia, and

21 literature.

22 Licensing and certification boards for

294 1 the practice of homeopathy have expressed

2 standards of ethics and informed consent for the

3 education of their clients and patients. It

4 assures the knowledge to make informed decisions.

5 It assures quality care.

6 Consumer educational outreach, as we

7 heard earlier, is the focus of the National Center

8 for Homeopathy, an IHPC member organization as a

9 partner for health, whose 5,000 plus members are

10 informed by a newsletter, magazine, webinars, and

11 annual conferences.

12 Media articles on homeopathic self care

13 are published in reputable wellness journals and

14 online sites, such as Mothering.com, as we just

15 heard, and Yoga Journal.

16 Homeopathic organizations and product

17 manufacturers also provide education and online

18 tools to prepare consumers to make informed

19 choices about homeopathic products for self

20 limiting conditions. Even before the recent new

21 world of consumer driven healthcare, our industry

22 has been educating consumers so they can make

295 1 better informed decisions.

2 IHPC's member organizations that

3 represent providers and consumers of homeopathic

4 products are vigilant in ensuring that consumers

5 have safe and clearly identified homeopathic

6 products to choose for their healthcare needs, and

7 access to the providers of their choice.

8 In the end, safe, effective choices for

9 healthcare providers and their patients are about

10 assuring quality, quality products, quality care,

11 quality of life.

12 Thank you for your attention.

13 DR. WHYTE: Thank you.

14 MS. WOSTREL: Thank you.

15 DR. WHYTE: Kate, is that -- okay. All

16 right. Let's start with Kate and then we'll go to

17 Rima, and then we'll go down the row.

18 DR. BENT: Thank you. Can you talk a

19 little bit about what type of information about

20 the manufacturing preparation of any homeopathic

21 products would be of benefit, either to the

22 practitioners in your organization or the

296 1 organizations in your organization?

2 MS. WOSTREL: I'm sorry, the

3 manufacturing?

4 DR. BENT: Any information about

5 manufacturing of the product that would be use to

6 the practitioners or to the organizations that you

7 represent?

8 MS. WOSTREL: The first thing that comes

9 to mind, of course, is the American Association of

10 Homeopathic Pharmacists as a resource for that

11 question as well, but we could also, for instance,

12 survey our practitioners of -- 400,000 plus

13 practitioners with those type of questions.

14 DR. IZEM: Hello. I have a question

15 related to your answer to question one. You seem

16 to make a distinction between single -- individual

17 homeopathic ingredient versus many ingredients.

18 Did I understand that correctly, that you have

19 that distinction?

20 And then a related question in response

21 to question two, when you cite sources of data on

22 risk benefit of homeopathic products, would that

297 1 be for single ingredients only?

2 MS. WOSTREL: Well, I didn't make a

3 distinction between single or complex homeopathy

4 in my presentation, so we could attempt to address

5 that in our written comments if that would be

6 helpful.

7 DR. IZEM: I guess I was referring to

8 your statement, "We understand that individual

9 homeopathic ingredients marketed for sale in the

10 U.S. have been reviewed for homeopathic efficacy,

11 toxicology, adverse events," etcetera.

12 MS. WOSTREL: Uh-huh.

13 DR. IZEM: So I thought you were making

14 a distinction between one ingredient versus many

15 ingredients, but --

16 MS. WOSTREL: I see. Yes, I -- well, I

17 can certainly understand how that would be the

18 implication, but it's not -- I don't think it's

19 the main point that we were trying to address.

20 MS. MICHELE: You concluded by

21 suggesting that we need clearly identified

22 homeopathic products for consumers to choose, and

298 1 I wonder if you could provide your recommendations

2 for how those products should be clearly

3 identified to differentiate them from non

4 homeopathic products?

5 MS. WOSTREL: Well, the label currently

6 is of any homeopathic product -- or products that

7 are labeled correctly, do state that they are

8 homeopathic or that they're labeled as homeopathic

9 medicine. That is appropriate, along with dose

10 information and the indication, so -- am I

11 answering your question?

12 MS. MICHELE: So, just to clarify, you

13 feel that if the product states somewhere on the

14 label that it has homeopathic, then that is

15 adequate labeling?

16 MS. WOSTREL: I think it's adequate

17 labeling to have it in typeface that is large

18 enough for the consumer to understand the

19 differentiation between a conventional OTC, and

20 that this is a homeopathic product.

21 And furthermore, other presenters had

22 indicated, and I agree, and IHPC would also be

299 1 comfortable with this position, that more consumer

2 information through the National Center for

3 Homeopathy or other sources -- more consumer

4 information about homeopathy, the distinction of

5 what homeopathy is, will be helpful I think for

6 consumers to make informed choice decisions.

7 MS. MICHELE: So do you feel that should

8 be on the principal display panel, or should it be

9 elsewhere on the product label in the drug facts?

10 Where are you suggesting that that needs to be on

11 the --

12 MS. WOSTREL: No, what I'm saying is I

13 think the labeling, if it's labeled correctly with

14 homeopathic, or as homeopathic medicine, is

15 adequate, but that other sources of information

16 and channels of information for curious consumers,

17 who are wanting to make informed choices, would be

18 helpful.

19 So more of what we are already doing

20 would be helpful to more consumers to make these

21 different choices and to continue making these

22 choices. Thank you.

300 1 DR. WHYTE: Dr. Nelson, do you have a

2 comment or --

3 DR. NELSON: A question.

4 DR. WHYTE: A question. Go right ahead.

5 DR. NELSON: I was struck by your phrase

6 "homeopathic efficacy," and so my question is, was

7 that just a turn of phrase as opposed to using

8 efficacy of homeopathic products, or did you mean

9 to imply that there's a different standard for

10 homeopathic versus non homeopathic efficacy?

11 MS. WOSTREL: Right. Thank you for that

12 question. No. I would say that that's in the

13 category of a turn of phrase.

14 DR. WHYTE: Any other questions?

15 (No audible response.)

16 DR. WHYTE: Okay. Well, thank you.

17 Next, I'd like to welcome Nancy Peplinsky from the

18 Holistic Mom's Network. You can say dad's, too.

19 MS. PEPLINSKY: It's dad's, too. I

20 promise you. We have many dad's in Holistic

21 Mom's.

22 Good afternoon. My name is Nancy

301 1 Peplinsky, and I'm the founder and Director of the

2 Holistic Mom's Network, which also welcomes dads,

3 a national 501(c)3 non-profit organization

4 connecting parents and others interested in

5 holistic health and green living. We were founded

6 12 years ago and have more than 100 chapters

7 across the United States.

8 I am here today, sponsored by the AAHP,

9 but I am representing myself and the 13,000 highly

10 engaged moms and dads who are members of the

11 Holistic Mom's Network, as well as our more than

12 92,000 social media friends and followers.

13 I am also the mother of two boys who

14 have been raised according to holistic and natural

15 lifestyle options, and prior to my motherhood

16 journey, I worked in academia and also in non-

17 profit organizations here in the D.C. area, and I

18 earned both my second master's and PhD right

19 around the corner from here at the University of

20 Maryland.

21 I was first introduced to homeopathy as

22 a graduate student by a fellow graduate student

302 1 who was using homeopathy to treat flu like

2 symptoms, and after I became a mom, I began

3 researching and using homeopathy with my family

4 with great success. That is my brief personal

5 background.

6 And I'd like to turn to a couple of the

7 questions set forth in the Federal Register

8 notice. The first concern I'd like to address is

9 the consumer and healthcare provider attitudes

10 toward homeopathic products.

11 My personal experience with homeopathy

12 is very reflective of the experiences of members

13 of the Holistic Mom's Network across the country.

14 For myself and for many of our members, homeopathy

15 has become one of our primary healthcare

16 modalities for several reasons.

17 First and foremost is safety. The high

18 quality and standards that currently apply to the

19 industry help to ensure that the products are

20 safe, reliable, and effective.

21 My older son has multiple allergies,

22 including those to dairy, soy, gluten, and corn,

303 1 and has had severe reactions to some of these

2 ingredients over the past years. Many of these

3 substances are present in conventional medicines

4 and formulas, along with flavorings and coloring,

5 which he is also sensitive to, and make these over

6 the counter medications often unavailable to him

7 for use. Homeopathy gives him a mechanism to

8 treat common conditions, such as colds, seasonal

9 allergies, even bumps and bruises, without the

10 fear of an allergic reaction.

11 Homeopathy is equally important for my

12 younger son who has special needs. He has a

13 number of ongoing issues, and he has a very bad

14 gag reflex as a result of intubation as an infant,

15 and he is unable to swallow a lot of pills or any

16 other medications unless they're in liquid format,

17 which is a little bit hard to get in some cases.

18 Homeopathic remedies give him a simple option for

19 common conditions as well, and helps overcome

20 these issues that he has to deal with and face.

21 Homeopathy works in conjunction with a

22 wide range of conventional integrative therapies

304 1 that I use with my family. They are not usually

2 exclusive from conventional medicine, but work

3 powerfully alongside of it.

4 Throughout the Holistic Mom's Network,

5 our members find homeopathic remedies are easy to

6 administer, they're easy to transport and have

7 available, they're easy to give because of their

8 sweet taste for children, and they're very useful,

9 and that they're not contraindicated with other

10 medicines.

11 Like many moms, and as a single mom, I

12 have limited time and a restricted budget. Having

13 access to homeopathic remedies helps empower me to

14 take care of my children effectively and

15 affordably, particularly for a wide range of

16 conditions that do not require prescriptions or a

17 doctor visit.

18 On a broader scale, homeopathy engages

19 parents by making them aware and responsive to

20 their children's symptoms. Homeopathy uses

21 individualized remedies specific to each child and

22 to each symptom, negating a "one size fits all"

305 1 approach, and customizing it to your child.

2 In my home, because we use homeopathy,

3 my kids are very in tune with their symptoms and

4 can express them very clearly. When one of my

5 children has an illness or a symptom, sometimes as

6 simple as a headache, we discuss the details of

7 exactly how he is experiencing it, and come up

8 with the best remedy to match his condition.

9 I think over the long term this makes

10 children much more attuned to their symptoms,

11 their bodies, and their physical health, which

12 will serve them over their lifetime.

13 The efficacy, safety, and ease of use

14 are the biggest reasons that homeopathy is so

15 popular throughout the Holistic Mom's Network.

16 Many of us have had tremendous success with

17 homeopathy, especially where conventional

18 therapies were not successful.

19 Both in my personal experience and in

20 the experience of Holistic Moms Network members,

21 indicate that the current oversight labeling and

22 information provided about homeopathic remedies is

306 1 adequate for consumers to make informed decisions

2 about the use of homeopathy.

3 Although homeopathy has been around for

4 over 200 years, many people in this country are

5 not familiar with its practice, and as a result,

6 education is a very important aspect of effective

7 use. Organizations like Holistic Moms Network

8 work with doctors of homeopathy to ensure that

9 parents understand the remedies and their uses.

10 To touch on another question posed in

11 the Federal Register, I believe that the

12 standardized packaging and labeling currently in

13 use makes these products very safe, even for the

14 novice consumer. Because the established makers of

15 homeopathic products have very high standards and

16 comply with the current regulations, their safety

17 concerns are very minimal.

18 As the voice of thousands of families

19 across the U.S., I find that parents do an

20 inordinate amount of research and consult with

21 healthcare professionals before using any wellness

22 product, either conventional or holistic.

307 1 I am not an expert in the regulatory

2 framework, but the policies and standards that the

3 FDA has provided for homeopathic remedies allows

4 families like mine to access these important

5 medications.

6 I am open to any questions, and thank

7 you for the opportunity to speak.

8 DR. WHYTE: Thank you.

9 DR. LOSTRITTO: Hi. Thank you. It was

10 said earlier today that people select homeopathic

11 products largely by first going and looking at

12 symptoms and then seeing what's available and

13 making a choice from that.

14 I'd like to ask, in your experience,

15 since you're so interested in homeopathy, do you -

16 - when you have a child or a family member with a

17 set of symptoms, do you set out to seek a

18 homeopathic remedy for those symptoms and match

19 it, or do you shop by looking at what treatments

20 are available, say over the counter, for that set

21 of symptoms in the aisle of a pharmacy, and do you

22 see any benefit in segregating products by type,

308 1 or by symptom?

2 MS. PEPLINSKY: Forgive me if I'm not

3 clear, but I think whether it's conventional or

4 holistic, most of us go with a set of symptoms in

5 mind. I mean, we definitely we're experiencing

6 flu like symptoms and so we'll go and look for

7 products that deal with that set of symptoms and

8 that protocol.

9 I specifically like to have all of the

10 options available in one place because it's not

11 just homeopathy that we use in our family. We

12 have found homeopathy to be extremely effective,

13 and so we do tend to choose homeopathic products,

14 but I am open to looking at all sorts of products

15 to find out which one is going to seemingly be the

16 best fit, and then also based on the ingredient

17 lists, because for me, as I said, with multiple

18 allergies I have to be very careful about label

19 reading, and so I have to know exactly what's in

20 the products that I'm going to then give to my

21 children.

22 DR. LOSTRITTO: Thank you.

309 1 MS. MICHELE: So thank you for sharing

2 your story and that of your sons. Just to follow

3 up on what you heard from Dr. Lostritto, with

4 regards to ensuring that your products that you

5 are purchasing would not have any interaction with

6 your son's allergies, how do you find that for the

7 homeopathic products? How do you ensure that they

8 are not containing any of those elements?

9 MS. PEPLINSKY: Like many parents, I

10 think we take advantage of the wide range of

11 resources that are available to us today.

12 Technology has been a boon for all of us. We can

13 all go online and Google pretty much anything.

14 I like to rely on certain very well

15 established and credible manufacturers of

16 homeopathic remedies and seek out information from

17 them through their websites, through the

18 information ingredients list and product lists on

19 their website as well as even contacting them

20 directly to find out exactly if their products

21 contain any of the allergens that I need to be

22 careful about.

310 1 And so I think as a parent, and as many

2 parents, especially with children with allergies,

3 we go through extraordinary lengths to ensure that

4 our children are safe using all of these and we

5 take that upon ourselves to do that.

6 It's always very helpful when a product

7 is labeled "allergen free" and lists that

8 allergens that it's free of. As a parent, I find

9 that incredibly useful, but if I need to go the

10 extra mile, I certainly will.

11 MR. PACE: When a mother or father comes

12 to you and asks what a homeopathic drug is, what

13 do you tell them?

14 MS. PEPLINSKY: I tell them that it's a

15 substance that works from a very small dilution of

16 a substance that works in the principles of "like

17 cures like" because that's how I understand

18 homeopathy in the most simplest form, and that it

19 stimulates a natural immune response to create

20 alleviation of symptoms.

21 That's my most simple explanation that I

22 can do for homeopathy, and I think it works for a

311 1 lot of people.

2 DR. WHYTE: Up next we have Tanya Kell

3 from the North American Society of Homeopaths.

4 MS. KELL: Good afternoon. My name is

5 Tanya Kell and I am here in the interest of the

6 public. Neither I nor those whom I represent

7 stand to gain to or lose financially from any

8 outcome of this hearing.

9 I am the President of the North American

10 Society of Homeopaths, as he said, and our

11 professional society of homeopathic practitioners

12 is modeled after the registered society of

13 homeopaths in England.

14 We require extensive training in

15 homeopathy and a broad understanding of its unique

16 principles as well as peer review and adherence to

17 a code of ethics for membership. We are involved

18 in shaping policy, creating educational standards,

19 and protecting the rights of both the homeopathic

20 consumer and provider, nationally and

21 internationally.

22 Our members have specialized knowledge

312 1 of homeopathic medicines and inform the public on

2 the use of those medicines according to standard

3 homeopathic indications for each particular

4 potentized (ph) drug.

5 We have a sincere concern for

6 maintaining an accurate and ethical reputation,

7 both for our members and for homeopathy as a

8 whole. It is our desire to aid the Food and Drug

9 Administration in evaluating and identifying the

10 veracity of the word "homeopathic" on any

11 particular drug label.

12 Almost all of the products labeled

13 homeopathic according to the FDA definition of the

14 term, that have generated FDA alerts and warning

15 letters over recent years, were not homeopathic

16 according to the principles of our profession and

17 of accepted homeopathic doctrine. Many of the

18 complaints currently filed under the heading,

19 "homeopathic products," would disappear if all of

20 the erroneous labeling were corrected.

21 It is still possible to enforce a

22 technically correct use of the word on drug

313 1 labels, and we believe it is in the best interest

2 of the public to do so.

3 It is up to the FDA to establish, much

4 as the Department of Agriculture did for organic,

5 criteria for accurate label usage of the word

6 "homeopathic."

7 There is a long, established record of

8 both safety and efficacy in homeopathy.

9 Homeopathic practice is based on hundreds of years

10 of clinical experience by both physicians in this

11 country and around the world.

12 The Homeopathic Pharmacopeia of the

13 United States is an accurate document as to the

14 preparation, origins, potencies, of truly

15 homeopathic products.

16 The current regulatory structure is

17 adequate to meet the needs of the consumer, both

18 in assuring product safety and consumer access.

19 However, the homeopathic professions viewpoint

20 must be considered in the regulatory agencies

21 determination of which products are sold to the

22 public as homeopathic.

314 1 According to the World Health

2 Organization, homeopathy is the second most widely

3 used form of medicine worldwide. It must remain

4 broadly accessible to an informed American public.

5 Thank you.

6 MR. LOSTRITTO: You make a very

7 passionate statement in the third paragraph. It

8 is up the FDA to establish, as much as the

9 Department of Agriculture did for organic, the

10 criteria for accurate label usage of the word

11 "homeopathic." What's your vision of how that

12 labeling would appear?

13 MS. KELL: That is in reference to the

14 linguistic drift that has been part of the

15 confusion that the word "homeopathic" means

16 natural, and the reputation of homeopathy has been

17 built on the good advice given by skilled,

18 trained, practitioners.

19 And so we want to ensure the good

20 reputation of homeopathy by not allowing that

21 linguistic drift to become entrenched.

22 MR. LOSTRITTO: I agree. As somebody

315 1 who is involved in labeling, linguistic drift is

2 the bane of what we try -- of what we do. But can

3 you be specific in how you would remedy that, what

4 you would like to see a label look like?

5 MS. KELL: That's been addressed a

6 little bit by some of the pharmacies. There's a

7 broad range of commonly used remedies that have

8 indications that can be spelled out clearly in a

9 few words, and we have those in our health food

10 stores.

11 There's also -- we have nearly 5,000

12 homeopathic remedies in use around the world, and

13 some of them you can't put a three word

14 description on a small bottle, and we would

15 encourage the use of "use according to standard

16 homeopathic indications," and so that lets people

17 know that they need to consult with someone who

18 has studies in depth.

19 MS. LIPPMANN: A couple of questions,

20 one teeing off of that. Does your definition of

21 homeopathy differ from what you understand FDA's

22 definition to be?

316 1 MS. KELL: No. The HPUS defines it

2 pretty well.

3 MS. LIPPMANN: Okay. And you say in -- I

4 guess it's your last paragraph -- that there's a

5 long, established record of both safety and

6 efficacy in homeopathy. Can you provide -- what

7 are the data sources for that long established

8 record, particularly with respect to efficacy.

9 What are you referring to?

10 MS. KELL: This is more a compilation of

11 anecdotal evidence, so when I studies social work

12 that was an accepted form of evidence, is just

13 compiling anecdotal stories.

14 Homeopathy has hundreds of millions of

15 those, and you know, as our reputation grows, so

16 does those anecdotal stories, and we feel that

17 they are a legitimate source of data.

18 MS. LIPPMANN: Okay. Thanks.

19 DR. WHYTE: So, I have some exciting

20 news to share. Our last speaker is not here.

21 That's not exciting. What is exciting is that

22 you're basically getting back 30 minutes of your

317 1 day, and we will conclude early.

2 I do have a few closing comments.

3 Everyone will need to sign in again tomorrow, so

4 please be sure to come here a bit early so you

5 have plenty of time to sign in.

6 In case you can't be here and you want

7 to watch it online, again, that website is

8 Collaboration.gov/hprApril2015.

9 And finally, I want to thank everyone on

10 behalf of Dr. Woodcock and myself. I know there's

11 lots of things that you could be doing on a Monday

12 in Silver Spring -- rather than coming to Silver

13 Spring, Maryland in a windowless room that is

14 sometimes hot, for seven and a half, eight hours.

15 So, it's certainly very helpful to hear

16 people's stories, their personal stories, their

17 professional perspectives on this issue.

18 So we know that there are many things

19 that you could be doing with your day and we're

20 very appreciative of the time that you've taken to

21 come today, to stick to the timelines, to be

22 collegial, and we look forward to that tomorrow as

318 1 well.

2 (Whereupon, at approximately 3:39 p.m.,

3 the hearing in the above matter was

4 concluded.)

319 1 CERTIFICATE OF NOTARY PUBLIC

2 I, MICHAEL FARKAS, the officer before whom the

3 foregoing deposition was taken, do hereby certify

4 that the witness whose testimony appears in the

5 foregoing deposition was duly sworn by me; that

6 the testimony of said witness was recorded by me

7 and thereafter reduced to typewriting under my

8 direction; that said deposition is a true record

9 of the testimony given by said witness; that I am

10 neither counsel for, related to, nor employed by

11 any of the parties to the action in which this

12 deposition was taken; and, further, that I am not

13 a relative or employee of any counsel or attorney

14 employed by the parties hereto, nor financially or

15 otherwise interested in the outcome of this

16 action.

19 ______MICHAEL FARKAS 20 Notary Public in and for the DISTRICT OF COLUMBIA 21

320 1 CERTIFICATE OF TRANSCRIPTION

4 I, ANNMARIE WASKO, hereby certify that I am not

5 the Court Reporter who reported the following

6 proceeding and that I have typed the transcript of

7 this proceeding using the Court Reporter's notes

8 and recordings. The foregoing/attached transcript

9 is a true, correct, and complete transcription of

10 said proceeding.

13 ______ANNMARIE WASKO 14 Transcriptionist

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